Surgical guidance system and method

ABSTRACT

A method for controlling a surgical tool includes associating a joint of a patient with a representation of the joint, collecting data indicating at least one of a position and an orientation of a first bone and a second bone of the joint as the joint is moved through a range of motion, and creating a surgical plan based at least in part on the data collected. The method further includes establishing a virtual cutting boundary on the representation of the joint based on the surgical plan, superimposing a representation of the surgical tool on the representation of the joint, wherein the surgical tool is to be operated by a user to execute the surgical plan during a surgical procedure, and controlling the surgical tool to prevent the surgical tool from cutting a portion of the joint outside a boundary that corresponds to the virtual cutting boundary.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/195,733, filed Aug. 1, 2011, which is a continuation of U.S. patentapplication Ser. No. 11/357,197, filed Feb. 21, 2006. U.S. patentapplication Ser. No. 11/357,197 is a continuation-in-part of U.S. patentapplication Ser. No. 10/384,072, filed Mar. 6, 2003, published Feb. 5,2004; U.S. patent application Ser. No. 10/384,077, filed Mar. 6, 2003,published Feb. 19, 2004; and U.S. patent application Ser. No.10/384,194, filed Mar. 6, 2003, published Feb. 19, 2004, each of whichclaims priority from U.S. Provisional Patent Application No. 60/362,368,filed Mar. 6, 2002. U.S. patent application Ser. No. 11/357,197 is alsoa continuation-in-part of U.S. patent application Ser. No. 10/621,119,filed Jul. 16, 2003, published Jun. 3, 2004, which is acontinuation-in-part of U.S. patent application Ser. No. 10/384,078,filed Mar. 6, 2003, published Feb. 19, 2004, which claims priority fromU.S. Provisional Patent Application Serial No. 60/362,368, filed Mar. 6,2002. U.S. patent application Ser. No. 11/357,197 further claimspriority from U.S. Provisional Patent Application Ser. No. 60/655,642,filed Feb. 22, 2005, and U.S. Provisional Patent Application Ser. No.60/759,186, filed Jan. 17, 2006. Each of the above-referenced publishedapplications is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The invention relates to a surgical system and, more particularly, to asurgical system and method for orthopedic joint replacement.

Description of Related Art

Minimally invasive surgery (MIS) is the performance of surgery throughincisions that are considerably smaller than incisions used intraditional surgical approaches. For example, in an orthopedicapplication such as total knee replacement surgery, an MIS incisionlength may be in a range of about 4 to 6 inches whereas an incisionlength in traditional total knee surgery is typically in a range ofabout 6 to 12 inches. As a result of the smaller incision length, MISprocedures are generally less invasive than traditional surgicalapproaches, which minimizes trauma to soft tissue, reducespost-operative pain, promotes earlier mobilization, shortens hospitalstays, and speeds rehabilitation.

One drawback of MIS is that the small incision size reduces a surgeon'sability to view and access the anatomy. For example, in minimallyinvasive orthopedic joint replacement, limited visibility and limitedaccess to the joint increase the complexity of assessing proper implantposition and of reshaping bone. As a result, accurate placement ofimplants may be more difficult. Conventional techniques forcounteracting these problems include, for example, surgical navigation,positioning the leg for optimal joint exposure, and employing speciallydesigned, downsized instrumentation and complex surgical techniques.Such techniques, however, typically require a large amount ofspecialized instrumentation, a lengthy training process, and a highdegree of skill. Moreover, operative results for a single surgeon andamong various surgeons are not sufficiently predictable, repeatable,and/or accurate. As a result, implant performance and longevity variesamong patients.

In orthopedic applications, one drawback of both MIS and traditionalsurgical approaches is that healthy as well as diseased bone is removedwhen the bone is prepared to receive the implant. For example, a totalknee replacement can require removal of up to ½ inch of bone on each ofthree compartments of the knee. One conventional solution for preservinghealthy bone is to perform a partial (or unicompartmental) kneereplacement where only one compartment of the knee is damaged. Aunicompartmental approach involves removal of damaged or arthriticportions on only one compartment of the knee. For example, the REPICCI®unicondylar knee system typically requires removal of only about ¼ inchof bone on one compartment of the knee. The REPICCI® system employsfreehand sculpting of bone with a spherical burr through a minimallyinvasive incision typically about 3 inches in length. The spherical burrenables cuts having rounded shapes that cannot be reproduced with asurgical saw. The freehand burring technique, however, is difficult tomaster and requires more artistic sculpting capability from the surgeonthan techniques utilizing traditional cutting jigs or saw guides. As aresult, freehand cutting requires a high degree of skill to achieveoperable results that are sufficiently predictable, repeatable, and/oraccurate. Moreover, the REPICCI® technique and traditional surgicalapproaches can not produce cuts having complex or highly curvedgeometries. Thus, such approaches typically require the removal of atleast some healthy bone along with the diseased/damaged bone.

Another drawback of both MIS and traditional orthopedic surgicalapproaches is that such approaches do not enhance the surgeon's inherentsurgical skill in a cooperative manner. For example, some conventionaltechniques for joint replacement include autonomous robotic systems toaid the surgeon. Such systems, however, typically serve primarily toenhance bone machining by performing autonomous cutting with a highspeed burr or by moving a drill guide into place and holding theposition of the drill guide while the surgeon inserts cutting toolsthrough the guide. Although such systems enable precise bone resectionsfor improved implant fit and placement, they act autonomously (ratherthan cooperatively with the surgeon) and thus require the surgeon tocede a degree of control to the robot. Additional drawbacks ofautonomous systems include the large size of the robot, poor ergonomics,the need to rigidly clamp the bone during registration and cutting,increased incision length for adequate robot access, and limitedacceptance by surgeons and regulatory agencies due to the autonomousnature of the system.

Other conventional robotic systems include robots that cooperativelyinteract with the surgeon. One drawback of conventional interactiverobotic systems is that such systems lack the ability to adapt surgicalplanning and navigation in real-time to a dynamic intraoperativeenvironment. For example, U.S. patent application Ser. No. 10/470,314(Pub. No. US 2004/0128026), which is hereby incorporated by referenceherein in its entirety, discloses an interactive robotic systemprogrammed with a three-dimensional virtual region of constraint that isregistered to a patient. The robotic system includes a three degree offreedom (3-DOF) arm having a handle that incorporates force sensors. Thesurgeon utilizes the handle to manipulate the arm to move the cuttingtool. Moving the arm via the handle is required so that the forcesensors can measure the force being applied to the handle by thesurgeon. The measured force is then used in controlling motors to assistor resist movement of the cutting tool. For example, during a kneereplacement operation, the femur and tibia of the patient are fixed inposition relative to the robotic system. As the surgeon applies force tothe handle to move the cutting tool, the interactive robotic system mayapply an increasing degree of resistance to resist movement of thecutting tool as the cutting tool approaches a boundary of the virtualregion of constraint. In this manner, the robotic system guides thesurgeon in preparing the bone by maintaining the cutting tool within thevirtual region of constraint. As with the above-described autonomoussystems, however, the interactive robotic system functions primarily toenhance bone machining. The interactive robotic system also requires therelevant anatomy to be rigidly restrained and the robotic system to befixed in a gross position and thus lacks real-time adaptability to theintraoperative scene. Moreover, the 3-DOF configuration of the arm andthe requirement that the surgeon manipulate the arm using the forcehandle results in limited flexibility and dexterity, making the roboticsystem unsuitable for certain MIS applications.

In view of the foregoing, a need exists for a surgical system that canreplace direct visualization in minimally invasive surgery, sparehealthy bone in orthopedic joint replacement applications, enableintraoperative adaptability and surgical planning, and produce operativeresults that are sufficiently predictable, repeatable, and/or accurateregardless of surgical skill level. A surgical system need notnecessarily meet all or any of these needs to be an advance, though asystem meeting these needs would me more desirable.

SUMMARY OF THE INVENTION

An aspect of the present invention relates to a surgical apparatus. Thesurgical apparatus includes a computer system and a surgical deviceconfigured to be manipulated by a user to perform a procedure on apatient. The computer system is programmed to implement controlparameters for controlling the surgical device to provide at least oneof haptic guidance to the user and a limit on user manipulation of thesurgical device, based on a relationship between an anatomy of thepatient and at least one of a position, an orientation, a velocity, andan acceleration of a portion of the surgical device, and to adjust thecontrol parameters in response to movement of the anatomy during theprocedure.

Another aspect of the present invention relates to a surgical apparatus.The surgical apparatus includes a haptic device configured to bemanipulated by a user to perform a procedure on a patient. The hapticdevice includes at least one feedback mechanism configured to supplyfeedback to the user manipulating the haptic device. The surgicalapparatus also includes a computer system programmed to implementcontrol parameters for controlling the at least one feedback mechanismto provide haptic guidance to the user, while the user manipulates thehaptic device, based on a relationship between an anatomy of the patientand at least one of a position, an orientation, a velocity, and anacceleration of a portion of the haptic device.

Yet another aspect of the present invention relates to a surgicalmethod. The surgical method includes creating a representation of ananatomy of a patient; associating the anatomy and a surgical device withthe representation of the anatomy; manipulating the surgical device toperform a procedure on a patient by moving a portion of the surgicaldevice in a region of the anatomy; controlling the surgical device toprovide at least one of haptic guidance and a limit on manipulation ofthe surgical device, based on a relationship between the representationof the anatomy and at least one of a position, an orientation, avelocity, and an acceleration of a portion of the surgical device; andadjusting the representation of the anatomy in response to movement ofthe anatomy during the procedure.

Yet another aspect of the present invention relates to a surgicalmethod. The surgical method includes creating a representation of ananatomy of a patient; associating the anatomy and a haptic device withthe representation of the anatomy; and manipulating the haptic device toperform a procedure on a patient by moving a portion of the hapticdevice in a region of the anatomy, where the haptic device includes atleast one feedback mechanism configured to supply feedback duringmanipulation. The surgical method further includes controlling the atleast one feedback mechanism to provide haptic guidance, duringmanipulation of the haptic device, based on a relationship between therepresentation of the anatomy of the patient and at least one of aposition, an orientation, a velocity, and an acceleration of a portionof the haptic device.

Yet another aspect of the present invention relates to a method forjoint replacement. The method includes creating a representation of afirst bone; creating a representation of a second bone; planning bonepreparation for implanting a first implant on the first bone; preparingthe first bone to receive the first implant by manipulating a surgicaltool to sculpt the first bone; planning bone preparation for implantinga second implant on the second bone after preparing the first bone; andpreparing the second bone to receive the second implant by manipulatingthe surgical tool to sculpt the second bone.

Yet another aspect of the present invention relates to a surgicalplanning method. The surgical planning method includes detecting aheight of a cartilage surface above a bone; creating a representation ofthe bone and a representation of the height of the cartilage surface;and planning bone preparation for implanting an implant on the bonebased at least in part on the detected height of the cartilage surface.

Yet another aspect of the present invention relates to a surgicalplanning method. The surgical planning method includes creating arepresentation of a bone of a joint; moving the joint to a firstposition; identifying a first point corresponding to a first location inthe joint, when the joint is in the first position; moving the joint toa second position; identifying a second point corresponding to a secondlocation in the joint, when the joint is in the second position; andplanning bone preparation for implanting an implant on the bone based atleast in part on the first and second points.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description serve to explain principles of theinvention.

FIG. 1 is a perspective view of an embodiment of a surgical systemaccording to the present invention.

FIG. 2A is a perspective view of an embodiment of a haptic deviceaccording to the present invention.

FIG. 2B is a perspective view of an embodiment of a haptic deviceaccording to the present invention.

FIG. 2C is a perspective view of the haptic device of FIG. 2A showing anembodiment of a manner of operating the haptic device according to thepresent invention.

FIG. 3 is a perspective view of an embodiment of an end effector of thehaptic device of FIG. 2A.

FIG. 4 is a perspective view of an embodiment of an anatomy trackeraccording to the present invention.

FIG. 5 is a perspective view of an embodiment of a haptic device trackeraccording to the present invention.

FIG. 6A is a perspective view of an embodiment of an end effectortracker according to the present invention.

FIG. 6B is a perspective view of the end effector of FIG. 5A attached toa haptic device.

FIG. 7 is a perspective view of an embodiment of an instrument trackeraccording to the present invention.

FIG. 8 is a view of an embodiment of a mechanical tracking systemaccording to the present invention.

FIG. 9 is a perspective view of a femur and a tibia showing anembodiment of a graphical representation of a haptic object according tothe present invention.

FIG. 10A is a perspective view of an embodiment of a femoral componentaccording to the present invention.

FIG. 10B is a perspective view of an embodiment of a tibial componentaccording to the present invention.

FIG. 11A is a graph of a force feedback curve according to an embodimentof the present invention.

FIG. 11B is a graph of the force feedback curve of FIG. 11A shifted tothe left.

FIG. 11C is a graphical representation of an embodiment of a repulsivehaptic object according to the present invention.

FIG. 11D is a graphical representation of an embodiment of a repulsivehaptic object according to the present invention.

FIG. 11E is a graphical representation of an embodiment of virtual toolaccording to the present invention.

FIG. 11F is a graphical representation of an embodiment of virtual toolaccording to the present invention.

FIG. 11G shows an embodiment of a graphical selection interfaceaccording to the present invention.

FIG. 11H shows an embodiment of a graphical selection interfaceaccording to the present invention.

FIG. 12 shows an embodiment of a display of a CAS system according tothe present invention.

FIG. 13 is a block diagram of an embodiment of a process for aunicondylar knee replacement according to the present invention.

FIG. 14A shows an embodiment of a leg holder according to the presentinvention.

FIG. 14B shows an embodiment of a leg holder according to the presentinvention.

FIG. 15 is a view of an embodiment of a surgical navigation screenshowing a segmentation step according to the present invention.

FIG. 16 is a view of an embodiment of a surgical navigation screenshowing a segmentation step according to the present invention.

FIG. 17 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 18 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 19 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 20 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 21 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 22 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 23 is a view of an embodiment of a surgical navigation screenshowing a landmark selection step according to the present invention.

FIG. 24 is a view of an embodiment of a surgical navigation screenshowing a probe calibration verification step according to the presentinvention.

FIG. 25 is a view of an embodiment of a surgical navigation screenshowing an anatomy tracker installation step according to the presentinvention.

FIG. 26 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 27 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 28 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 29 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 30 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 31 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 32 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 33 is a view of an embodiment of a surgical navigation screenshowing a registration step according to the present invention.

FIG. 34 is a view of an embodiment of a surgical navigation screenshowing a haptic device calibration step according to the presentinvention.

FIG. 35 is a view of an embodiment of a surgical navigation screenshowing an implant placement planning step according to the presentinvention.

FIG. 36 is a view of an embodiment of a surgical navigation screenshowing a bone preparation step according to the present invention.

FIG. 37 is a view of an embodiment of a surgical navigation screenshowing a bone preparation step according to the present invention.

FIG. 38 is a view of an embodiment of a surgical navigation screenshowing an implant placement planning step according to the presentinvention.

FIG. 39 is a view of an embodiment of a surgical navigation screenshowing a bone preparation step according to the present invention.

FIG. 40 is a block diagram of an embodiment of a haptic renderingprocess according to the present invention.

FIG. 41 is a representation of multiple haptic objects that aresuperimposed.

FIG. 42 is a representation of an embodiment of a 3D geometric hapticobject according to the present invention.

FIG. 43 is a block diagram of an embodiment of a polygon based hapticrendering process according to the present invention.

FIG. 44 is a representation of an embodiment of a polygon surface objectaccording to the present invention.

FIG. 45 is a representation of an embodiment of a voxel map according tothe present invention.

FIG. 46A is a representation of an embodiment of a voxel lookup tableaccording to the present invention.

FIG. 46B is a representation of an embodiment of a polygon lookup tableaccording to the present invention.

FIG. 47 illustrates an implementation of an embodiment of a virtualguide line according to the present invention.

FIG. 48 is a graphical illustration of a coordinate transformation.

FIG. 49A is an illustration of a virtual proxy point location.

FIG. 49B is an illustration of a virtual proxy point location.

FIG. 50 is a flowchart of an embodiment of a haptic rendering algorithmaccording to the present invention.

FIG. 51A is an pictorial representation of an active polygon prioritybehavior.

FIG. 51B is a pictorial representation of an On-Polygon prioritybehavior.

FIG. 51C is a pictorial representation of a continuous surface prioritybehavior.

FIG. 51D is a pictorial representation of a minimum force prioritybehavior.

FIG. 52A is a pictorial representation of an x-y view of an augmentingconcave corner behavior.

FIG. 52B is a pictorial representation of a y-z view of an augmentingconcave corner behavior.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Presently preferred embodiments of the invention are illustrated in thedrawings. Although this specification refers primarily to orthopedicprocedures involving the knee joint, it should be understood that thesubject matter described herein is applicable to other joints in thebody, such as, for example, a shoulder, elbow, wrist, spine, hip, orankle and to any other orthopedic and/or musculoskeletal implant,including implants of conventional materials and more exotic implants,such as orthobiologics, drug delivery implants, and cell deliveryimplants.

FIG. 1 shows an embodiment of a surgical system 10 according to thepresent invention. The surgical system 10 includes a computing system20, a haptic device 30, and a tracking (or localizing) system 40. Inoperation, the surgical system 10 enables comprehensive, intraoperativesurgical planning. The surgical system 10 also provides haptic guidanceto a user (e.g., a surgeon) and/or limits the user's manipulation of thehaptic device 30 as the user performs a surgical procedure.

The computing system 20 includes hardware and software for operation andcontrol of the surgical system 10. As shown in FIG. 1, the computingsystem 20 includes a computer 21, a display device 23, and an inputdevice 25. The computing system 20 may also include a cart 29.

The computer 21 may be any known computing system but is preferably aprogrammable, processor-based system. For example, the computer 21 mayinclude a microprocessor, a hard drive, random access memory (RAM), readonly memory (ROM), input/output (I/O) circuitry, and any otherwell-known computer component. The computer 21 is preferably adapted foruse with various types of storage devices (persistent and removable),such as, for example, a portable drive, magnetic storage (e.g., a floppydisk), solid state storage (e.g., a flash memory card), optical storage(e.g., a compact disc or CD), and/or network/Internet storage. Thecomputer 21 may comprise one or more computers, including, for example,a personal computer (e.g., an IBM-PC compatible computer) or aworkstation (e.g., a SUN or Silicon Graphics workstation) operatingunder a Windows, MS-DOS, UNIX, or other suitable operating system andpreferably includes a graphical user interface (GUI). In one embodiment,the computer 21 includes a Navigation Module available from MAKOSURGICAL CORP™ and identified by product number 0040TAS00001.

The display device 23 is a visual interface between the computing system20 and the user. The display device 23 is connected to the computer 21and may be any device suitable for displaying text, images, graphics,and/or other visual output. For example, the display device 23 mayinclude a standard display screen (e.g., LCD, CRT, plasma, etc.), atouch screen, a wearable display (e.g., eyewear such as glasses orgoggles), a projection display, a head-mounted display, a holographicdisplay, and/or any other visual output device. The display device 23may be disposed on or near the computer 21 (e.g., on the cart 29 asshown in FIG. 1) or may be remote from the computer 21 (e.g., mounted ona wall of an operating room or other location suitable for viewing bythe user). The display device 23 is preferably adjustable so that theuser can position/reposition the display device 23 as needed during asurgical procedure. For example, the display device 23 may be disposedon an adjustable arm (not shown) that is connected to the cart 29 or toany other location well-suited for ease of viewing by the user. Thedisplay device 23 may be used to display any information useful for amedical procedure, such as, for example, images of anatomy generatedfrom an image data set obtained using conventional imaging techniques,graphical models (e.g., CAD models of implants, instruments, anatomy,etc.), graphical representations of a tracked object (e.g., anatomy,tools, implants, etc.), digital or video images, registrationinformation, calibration information, patient data, user data,measurement data, software menus, selection buttons, status information,and the like.

In addition to the display device 23, the computing system 20 mayinclude an acoustic device (not shown) for providing audible feedback tothe user. The acoustic device is connected to the computer 21 and may beany known device for producing sound. For example, the acoustic devicemay comprise speakers and a sound card, a motherboard with integratedaudio support, and/or an external sound controller. In operation, theacoustic device may be adapted to convey information to the user. Forexample, the computer 21 may be programmed to signal the acoustic deviceto produce a sound, such as a voice synthesized verbal indication“DONE,” to indicate that a step of a surgical procedure is complete.Similarly, the acoustic device may be used to alert the user to asensitive condition, such as producing a beep to indicate that asurgical cutting tool is nearing a critical portion of soft tissue.

The input device 25 of the computing system 20 enables the user tocommunicate with the surgical system 10. The input device 25 isconnected to the computer 21 and may include any device enabling a userto provide input to a computer. For example, the input device 25 can bea known input device, such as a keyboard, a mouse, a trackball, a touchscreen, a touch pad, voice recognition hardware, dials, switches,buttons, a trackable probe, a foot pedal, a remote control device, ascanner, a camera, a microphone, and/or a joystick.

The computing system 20 (in whole or in part) may be disposed on thecart 29 to economize space, minimize a physical footprint of thecomputing system 20, and/or permit portability. The cart 29 may be, forexample, a known cart, platform, or equipment stand and is preferablyconfigured for ease of mobility of the computing system 20. For example,as shown in FIG. 1, the cart 29 may include rolling members 28 (e.g.,wheels or casters) to enable the cart 29 to be moved. The cart 29 mayalso include a mechanism for securing the cart 29 in position. Forexample, the cart 29 may be equipped with wheel locks or brakes for therolling members 28, a foot pedal locking device, jack stands, and/or anyother known mechanism for securing a cart in position. In this manner,the cart 29 enables the computing system 20 to be moved from onelocation to another, positioned as necessary for each surgical case, andsecured in a desired position during storage and surgery. Alternatively,the computing system 20 (in whole or in part) may be installed in a roomwhere a surgical procedure will be performed (e.g., mounted on a wall orworkstation), installed in a remote location, integrated with the hapticdevice 30, integrated with an imaging device (e.g., a computedtomography (CT) device, a magnetic resonance imaging (MRI) device, afluoroscopic device, an ultrasound device, etc.), and/or integrated withan medical system (e.g., a medical equipment cart in a room where asurgical procedure will be performed).

The computing system 20 is adapted to enable the surgical system 10 toperform various functions related to surgical planning, navigation,image guidance, and/or haptic guidance. For example, the computer 21 mayinclude algorithms, programming, and software utilities related togeneral operation, data storage and retrieval, computer aided surgery(CAS), applications, haptic control, and/or any other suitablefunctionality. In one embodiment, the computing system 20 includessoftware used in a Navigation Module currently available from MAKOSURGICAL CORP™ and identified by product number 0040TAS00001.

Utilities related to general operation are configured to provide basiccomputing functions that enable and support overall operation of thesurgical system 10. General operation utilities may include, forexample, well known features such as functions for fast graphicsprocessing, functions for supporting input/output (I/O) devices,functions for connecting to a hospital network, functions for managingdatabase libraries (e.g., implant and instrument databases), functionsfor system security (e.g., login features, access restrictions, etc.),and/or any other functionality useful for supporting overall operationof the surgical system 10.

Utilities related to data storage and retrieval are configured to enablestorage of and access to various forms of data, such as image data(e.g., two- or three-dimensional image data sets obtained using anysuitable imaging modality, such as, for example, x-ray, computedtomography (CT), magnetic resonance (MR), positron emission tomography(PET), single photon emission computed tomography (SPECT), ultrasound,etc.), application data, implant data, instrument data, anatomical modeldata, patient data, user preference data, and the like. The data storageand retrieval utilities may include any functionality appropriate forstoring and handling relevant data.

Utilities related to computer aided surgery are configured to enablesurgical planning, navigation, and basic image guided surgerycapabilities. For example, as is well known, the CAS utilities mayinclude functions for generating and displaying images from image datasets, functions for determining a position of a tip and an orientationof an axis of a surgical instrument, and functions for registering apatient and an image data set to a coordinate frame of the trackingsystem 40. These functions enable, for example, the computing system 20to display on the display device 23 a virtual representation of atracked surgical instrument overlaid on one or more images of apatient's anatomy and to update the virtual representation of thetracked instrument in real time during a surgical procedure. Imagesgenerated from the image data set may be two-dimensional or, in the caseof a three-dimensional image data set, a three-dimensionalreconstruction based, for example, on segmentation of the image dataset. When more than one image is shown on the display device 23, thecomputing system 20 preferably coordinates the representation of thetracked instrument among the different images. In addition to or in lieuof images generated from image data sets, the computing system 20 mayuse anatomical models (e.g., based on CAD models, line art, sketches,cartoons, artist renderings, generic or morphed data sets, etc.).

Utilities related to applications of the surgical system 10 includeapplication specific programs configured to assist the user withsurgical planning and navigation. Programs associated with theapplication utilities may be configured for use in various medicalprocedures and/or may be customized for a specific procedure. Forexample, the application utilities may include programs related to oneor more orthopedic procedures, such as, for example, total kneereplacement, partial knee replacement, hip replacement, shoulderreplacement, elbow replacement, wrist replacement, ankle replacement,spinal surgery, and/or installation of orthopedic and/or musculoskeletalimplants, including implants of conventional materials and more exoticimplants, such as orthobiologics, drug delivery implants, and celldelivery implants. The application utilities may be directed to variousaspects of surgical planning and navigation, including pre-operative,intra-operative, and post-operative activities. For example, theapplication utilities may include programs or processes directed toplanning and set up, such as, for example, system initializationprocesses, planning processes, visualization processes, diagnosticimaging processes, registration processes, and calibration processes.The application utilities may also include programs or processesdirected to object tracking and system control, such as, for example,coordinate transform processes, interpolation processes, tool and powercontrol processes, anatomy positioning processes, mode controlprocesses, safety processes, occlusion detection algorithms, and forwardkinematics algorithms. The application utilities may include programs orprocesses related to the haptic device 30, such as, for example, hapticforce computation processes, haptic force mapping processes, processesfor generating haptic objects, and haptic rendering algorithms. Theapplication utilities may also include programs and processes forcommunicating with the user during a surgical procedure, such as, forexample, software for displaying pages or images corresponding tospecific steps of a surgical procedure, software for prompting a user toperform a certain task, and software for providing feedback (e.g.,visual, audible, tactile, and/or force feedback) to the user.

Utilities related to haptic control are configured to perform variousfunctions related to control, performance, stability, and/or safety ofthe haptic device 30. For example, the haptic control utilities mayinclude a real time operating system (RTOS), motion control software,hardware and software for generating high frequency updates for controlof the haptic device 30, software for ensuring failsafe operation of thehaptic device 30 (e.g., control of brakes, monitoring of redundantsensors, etc.), and/or any other utility suitable for improving orpromoting performance, stability, and/or safety of the haptic device 30.The haptic control utilities may be executed on the computer 21 of thecomputing system 20 provided the computer 21 has a computingarchitecture sufficient to support the operating requirements of thehaptic control utilities. For example, processes associated with hapticcontrol typically have higher operational frequency requirements thatother processes running on the computer 21. In one embodiment, thehaptic control processes operate at a frequency of approximately 2 kHz.In another embodiment, the haptic control processes operate at afrequency in a range of between about 0.1 kHz to about 10 kHz. In yetanother embodiment, the haptic control processes operate at a frequencyin a range of between about 500 Hz to about 2,400 Hz. In contrast, thecomputer 21 may operate at a substantially lower frequency, such as, forexample, a frequency in a range of about 15 Hz to about 20 Hz. Inanother embodiment, the frequency of the computer 21 may be in a rangeof between about 2 Hz to about 60 Hz. In other embodiments, thefrequency of the computer 21 may be substantially equivalent to theoperating frequency required by the haptic control processes (e.g.,approximately 2 kHz). If the computer 21 does not have an architecturesufficient to support operation of the haptic control processes, thecomputing system 20 may include a computer 31 for execution of thehaptic control utilities. In a preferred embodiment, the computer 31 isintegrated or embedded with the haptic device 30.

The computer 31 (shown in FIG. 1) may be similar to the computer 21 butis preferably configured to satisfy specific operational requirements ofthe haptic device 30, such as, for example, the need for higheroperating frequencies. The computer 31 may comprise one or morecomputers. In one embodiment, the computer 31 is an Intel compatible x863U CompactPCI single-board computer with a processor clock speed of atleast 1.6 GHz, at least 2 GByte of non-volatile storage (e.g., hard diskdrive, Compact FLASH, etc.), at least 256 MB of RAM, 400 MHz Front SideBus or faster, at least 1 MByte of Level 2 cache memory, and a real-timeoperating system. One such commercially available embodiment includesthe ICP-PM-1004-DG-8A computer from Inova Computers GmbH, used with theQNX 6.1 (or later) operating system from QNX Software Systems Ltd.

In addition to the haptic control utilities, the computer 31 may includeprograms that enable the haptic device 30 to utilize data from thetracking system 40. For example, the tracking system 40 may generatetracked object pose (e.g., position and orientation) data periodically.In one embodiment, the object pose data is generated approximately 30times a second or 30 Hz. In other embodiments, object pose data isgenerated more frequently such as, for example, at approximately 500 Hzor greater. The object posed data is transferred from the trackingsystem 40 to the computer 31 (e.g., via an interface 100 b) and may beconditioned in any conventional manner such as, for example, using anoise filter as is well known. Additionally, in embodiments where thetracking system 40 operates at a lower frequency than the haptic controlprocesses, the object pose data may be conditioned using aninterpolation filter as is well known. The interpolation filter smoothesthe object pose data by populating gaps between discrete data samples toenable the object pose data to be used in the higher frequency hapticcontrol processes. The computer 31 may also include a coordinatetransform process for mapping (or transforming) coordinates in one spaceto those in another to achieve spatial alignment or correspondence. Forexample, the surgical system 10 may use the coordinate transform processto map positions of tracked objects (e.g., surgical tools, patientanatomy, etc.) into a coordinate system used by a process running on thecomputer 31 and/or the computer 21. As is well known, the coordinatetransform process may include any suitable transformation technique,such as, for example, rigid-body transformation, non-rigidtransformation, affine transformation, and the like.

One advantage of including multiple computers (e.g., the computer 21 andthe computer 31) in the computing system 20 is that each computer can beindependently configured. Thus, the computer 21 can be customized forsurgical planning and navigation, and the computer 31 can be customizedfor controlling performance, stability, and/or safety of the hapticdevice 30. For example, the computer 31 may include a real timeoperating system (RTOS) to maintain dependable updates to the hapticcontrol system and a stable operating platform for the haptic device 30.In contrast, the computer 21 may include a non-RTOS because thecomputing system 20 may not require the same degree of stability as thehaptic device 30. Thus, the computer 21 may instead be customized tomeet specific requirements of surgical navigation, such as, for example,graphics processing. Another advantage of multiple computers havingseparate computing architectures is that software developers withlimited knowledge of haptic systems can create CAS utilities for thecomputer 21 that can be used in conjunction with a variety of hapticdevices. Similarly, software developers with limited knowledge of CAScan create haptic utilities focused on enhancing the performance,stability, and/or safety of a particular haptic device. As analternative to separate computers, the computing functions of the hapticdevice 30 and the computing system 20 may be incorporated, for example,into a single computer (e.g., the computer 21 or the computer 31), intoa computing system of an imaging device (e.g., a CT device, an MMdevice, a fluoroscopic device, etc.), and/or into a hospital computingsystem (e.g., a network system, an equipment cart in a room where thesurgical procedure will be performed, etc.).

As shown in FIG. 1, the computing system 20 is coupled to the hapticdevice 30 via an interface 100 a. The interface 100 a includes aphysical interface and a software interface. The physical interface maybe any known interface such as, for example, a wired interface (e.g.,serial, USB, Ethernet, CAN bus, and/or other cable communicationinterface) and/or a wireless interface (e.g., wireless Ethernet,wireless serial, infrared, and/or other wireless communication system).The software interface may be resident on the computer 21 and/or thecomputer 31 and enables the computing system 20 to communicate with andcontrol operation of the haptic device 30. In one embodiment, thesoftware interface includes a utility that allows the computing system20 to issue commands to the haptic device 30. For example, the computer21 may send a command to the computer 31 requesting the haptic device 30to enter a specific mode (e.g., approach mode, haptic mode, free mode,input mode, hold mode). In response, the computer 31 may be programmedto check various parameters to verify that entry into the requested modeis safe and otherwise acceptable and to either enter the haptic device30 into the requested mode or return an appropriate error message.

The haptic device 30 is a surgical device configured to be manipulatedby a user to move a surgical tool 50 to perform a procedure on apatient. During the procedure, the computing system 20 implementscontrol parameters for controlling the haptic device 30 based, forexample, on a relationship between an anatomy of the patient and aposition, an orientation, a velocity, and/or an acceleration of aportion of the haptic device 30 (e.g., the surgical tool 50). In oneembodiment, the haptic device 30 is controlled to provide a limit onuser manipulation of the device (e.g., by limiting the user's ability tophysically manipulate the haptic device 30). In another embodiment, thehaptic device 30 is controlled to provide haptic guidance (i.e., tactileand/or force feedback) to the user. “Haptic” refers to a sense of touch,and the field of haptics involves research relating to human interactivedevices that provide tactile and/or force feedback to an operator.Tactile feedback generally includes tactile sensations such as, forexample, vibration, whereas force feedback refers to feedback in theform of force (e.g., resistance to movement) and/or torque (also knownas “wrench). Wrench includes, for example, feedback in the form offorce, torque, or a combination of force and torque.

Guidance from the haptic device 30 coupled with computer aided surgery(CAS) enables a surgeon to actively and accurately control surgicalactions (e.g., bone cutting) and delivery of localized therapies (e.g.,in the brain). For example, the computing system 20 may be programmed todetermine the control parameters based on data representative of apatient's anatomy (e.g., preoperative CT image data, ultrasound data); avirtual (or haptic) object associated with (or registered to) theanatomy; a parameter relative to the anatomy (e.g., a depth defined withrespect to a portion of the anatomy); and/or the anatomy. The computingsystem 20 can control the haptic device 30 to generate a force, atorque, and/or vibration based on the position of the tool 50 relativeto the virtual object, the parameter, and/or the anatomy. For example,the tool 50 may be constrained against penetrating a virtual boundaryassociated with a representation of the anatomy and/or constrainedagainst exceeding a parameter defined with respect to the representationof the anatomy. Thus, in operation, as a surgeon manipulates the hapticdevice 30 to move the tool 50, virtual pathways may be used to guide thetool 50 to specific targets, virtual boundaries may be used to definecutting shapes or to prevent the tool 50 from contacting criticaltissue, and predefined parameters may be used to limit travel of thetool 50 (e.g., to a predefined depth). The computing system 20 may alsobe programmed to adjust the control parameters in response to movementof the physical anatomy during the procedure (e.g., by monitoringdetected movement of the physical anatomy and then adjusting the virtualobject in response to the detected movement). In this manner, thesurgical system 10 can supplement or replace direct visualization of thesurgical site, enhance the surgeon's natural tactile sense and physicaldexterity, and facilitate the targeting, repairing, and replacing ofvarious structures in the body through conventionally sized portals(e.g., 12 inches or greater in length) to portals having a diameter assmall as approximately 1 mm.

In orthopedic applications, for example, the haptic device 30 can beapplied to the problems of inaccuracy, unpredictability, andnon-repeatability in bone preparation by assisting the surgeon withproper sculpting of bone to thereby enable precise, repeatable boneresections while maintaining intimate involvement of the surgeon in thebone preparation process. Moreover, because the haptic device 30haptically guides the surgeon in the bone cutting operation, the skilllevel of the surgeon is less critical. As a result, surgeons withvarying degrees of skill and experience are able perform accurate,repeatable bone resections. In one embodiment, for example, a surgicaltool is coupled to the haptic device 30. The surgeon can operate thetool to sculpt bone by grasping and moving the tool and/or by graspingand manipulating the haptic device 30 to move the tool. As the surgeonperforms the cutting operation, the surgical system 10 tracks thelocation of the tool (with the tracking system 40) and, in most cases,allows the surgeon to freely move the tool in the workspace. When thetool is in proximity to a virtual boundary in registration with thepatient, however, the surgical system 10 controls the haptic device 30to provide haptic guidance that tends to constrain the surgeon frompenetrating the virtual boundary with the tool. For example, the virtualboundary may be defined by a haptic object, and the haptic guidance maycomprise an output wrench (i.e., force and/or torque) that is mapped tothe haptic object and experienced by the surgeon as resistance tofurther tool movement in the direction of the virtual boundary. Thus,the surgeon may feel as if the tool has encountered a physical object,such as a wall. In this manner, the virtual boundary functions as avirtual cutting guide. Thus, the haptic device 30 communicatesinformation to the surgeon regarding the location of the tool relativeto the virtual boundary and provides physical guidance in the actualcutting process. The haptic device 30 may also be configured to limitthe user's ability to manipulate the surgical tool as described, forexample, in U.S. patent application Ser. No. 10/470,314 (Pub. No. US2004/0128026), which is hereby incorporated by reference herein in itsentirety.

The haptic device 30 may include a mechanical or electro-mechanicaldevice adapted to transmit tactile feedback (e.g., vibration) and/orforce feedback (e.g., wrench) to the user. The haptic device 30 may berobotic, non-robotic, or a combination of robotic and non-roboticsystems. For example, the haptic device 30 may include a haptic deviceas described in U.S. patent application Ser. No. 10/384,072, filed Mar.6, 2003, published Feb. 5, 2004; U.S. patent application Ser. No.10/384,077, filed Mar. 6, 2003, published Feb. 19, 2004; U.S. patentapplication Ser. No. 10/384,078, filed Mar. 6, 2003, published Feb. 19,2004; U.S. patent application Ser. No. 10/384,194, filed Mar. 6, 2003,published Feb. 19, 2004; U.S. patent application Ser. No. 10/621,119,filed Jul. 16, 2003, published Jun. 3, 2004; and/or U.S. ProvisionalPatent Application Ser. No. 60/655,642, filed Feb. 22, 2005. Each of theabove-referenced published applications is hereby incorporated byreference herein in its entirety.

In one embodiment, the haptic device 30 comprises a robot. In thisembodiment, as shown in FIG. 2A, the haptic device 30 includes a base32, an arm 33, an end effector 35, and a user interface 37. The hapticdevice 30 may also include a platform 39.

The base 32 provides a foundation for the haptic device 30. As shown inFIG. 2, the base 32 supports the arm 33 and may also house and/orsupport other components of the haptic device 30, such as, for example,controllers, amplifiers, actuators, motors, transmission components,clutches, brakes, power supplies, sensors, computer hardware, and/or anyother well-known robotic component. The base 32 may be made of anysuitable metallic and/or synthetic material, such as, for example,aluminum or plastic, and preferably includes removable panels to provideaccess to components housed within the base 32.

The arm 33 is disposed on the base 32 and is adapted to enable thehaptic device 30 to be manipulated by the user. The arm 33 may be anysuitable mechanical or electromechanical structure but is preferably anarticulated arm having four or more degrees of freedom (or axes ofmovement), such as, for example, a robotic arm known as the “Whole-ArmManipulator” or WAM™ currently manufactured by Barrett Technology, Inc.In one embodiment, the arm 33 includes a first segment 33 a, a secondsegment 33 b, and a third segment 33 c as shown in FIG. 2A. The firstsegment 33 a and the second segment 33 b are connected at a first joint33 d (e.g., a shoulder joint), and the second segment 33 b and the thirdsegment 33 c are connected at a second joint 33 e (e.g., an elbowjoint). As shown in FIG. 2B, the arm 33 may have, for example, a firstdegree of freedom DOF₁, a second degree of freedom DOF₂, a third degreeof freedom DOF₃, and a fourth degree of freedom DOF₄. Thus, the segments33 a, 33 b, and 33 c and the joints 33 e and 33 d form an articulatingmechanical linkage that can be manipulated into various positions orposes. The arm 33 is sized to be appropriate for use in a variety ofprocedures, such as orthopedic, neurological, and/or trauma procedures,and to be sufficiently compact to enable mobility of the haptic device30 and efficient positioning of the haptic device 30 in an operatingroom. For example, the arm 33 may be sized slightly larger than a humanarm. In one embodiment, the arm 33 has a reach of approximately 1 m, anda diameter of the segments 33 b and 33 c is approximately 89 mm. The arm33 may also be adapted to house and/or route components of the hapticdevice 30, such as, for example, instrumentation, power lines, motors,transmission components, controllers, actuators, amplifiers, brakes,clutches, power supplies, sensors, and/or computer hardware. Forexample, the segments 33 a, 33 b, and 33 c may include internal channelsand/or hollow portions within which components of the haptic device 30may be disposed. The segments 33 a, 33 b, and 33 c may be made of anysuitable metallic and/or synthetic material, such as, for example,aluminum or plastic, and preferably include removable panels and/oraccess ports to enable access to components housed within the arm 33.

Dexterity of the arm 33 may be enhanced, for example, by addingadditional degrees of freedom. For example, the arm 33 may include awrist 36. As shown in FIG. 2A, the wrist 36 may be disposed on the arm33 (e.g., at a distal end of the third segment 33 c) and includes one ormore degrees of freedom to augment the degrees of freedom DOF₁, DOF₂,DOF₃, and DOF₄ of the arm 33. For example, as shown in FIG. 2B, thewrist 36 may include a degree of freedom DOF₅. In one embodiment, thewrist 36 includes two degrees of freedom, and the degree of freedom DOF₃of the arm 33 is eliminated. The wrist 36 may also be a one degree offreedom or a three degree of freedom WAM™ wrist manufactured by BarrettTechnology, Inc.

The arm 33 incorporates a feedback mechanism to enable the haptic device30 to communicate information to the user while the user manipulates thehaptic device 30. In operation, the computing system 20 controls thefeedback mechanism to generate and convey tactile and/or force feedbackto the user to communicate, for example, information about a location ofa portion of the haptic device (e.g., the tool 50) relative to a virtualobject, a parameter relative to the anatomy, and/or the anatomy. Thefeedback mechanism is preferably configured to produce force, torque,and/or vibration. The feedback mechanism may incorporate a drive system(not shown) comprising one or more actuators (e.g., motors) and amechanical transmission. The actuators are preferably adapted to supplyforce feedback opposing the user's manipulation of the haptic device 30.The actuators may include, for example, a samarium-cobalt brushlessmotor driven by sinusoidally-commutated current amplifier/controllers, aneodymium-iron brushless motor driven by space-vector-commutated currentamplifier/controllers, and/or any other suitable motor and commutationscheme suitable for use in a robotic system. The transmission may be,for example, a tension-element drive system (e.g., a cable, steel tape,or polymeric tendon transmission), a direct drive system, and/or anyother low static friction and low backlash transmission system suitablefor use in a robotic system. In an exemplary embodiment, the drivesystem includes a high-speed cable transmission and zero backlash, lowfriction, cabled differentials. In one embodiment, the cabletransmission may be a cable transmission used in the WAM™ robotic armmanufactured by Barrett Technology, Inc. and/or a cable transmission asdescribed in U.S. Pat. No. 4,903,536, which is hereby incorporated byreference herein in its entirety. One advantage of a cable transmissionis that the cable transmission permits most of the bulk of the arm 33 tobe disposed a sufficient distance from the surgical site so that theuser is not hindered or impeded by the structure or components of thearm 33 during a surgical procedure. The drive system is preferablyconfigured for low friction, low inertia, high stiffness, largebandwidth, near-zero backlash, force fidelity, and/or backdrivabilityand may also be also be adapted to help maintain the arm 33 in a statewhere the user perceives the arm 33 as weightless. For example, in oneembodiment, the arm 33 may have a configuration that is substantiallybalanced. Any imbalance in the arm (e.g., due gravitational effects) canbe counteracted, for example, by controlling the drive system togenerate forces and/or torques to correct the imbalanced condition. Themotors of the drive system may also be configured to produceoscillations or vibrations so that the haptic device 30 can providetactile feedback to the user. In addition to the drive system, thefeedback mechanism may also include a vibratory device, such as anoscillator, separate from the motors for producing vibration.

The arm 33 may include position sensors (not shown) for determining aposition and orientation (i.e., pose) of the arm 33. The positionsensors may include any known sensor for determining or tracking aposition of an object, such as, for example, encoders, resolvers,potentiometers, linear variable differential transformers (LVDTs), tiltsensors, heading (compass) sensors, gravity direction sensors (e.g.,accelerometers), optical sensors (e.g., infrared, fiber optic, or lasersensors), magnetic sensors (e.g., magnetoresistive or magnetorestrictivesensors), and/or acoustic sensors (e.g., ultrasound sensors). Theposition sensors may be disposed at any suitable location on or withinthe haptic device 30. For example, the position sensors may includeencoders mounted on the joints 33 d and 33 e and/or resolvers mounted ona shaft of each motor. The pose of the arm 33 may also be tracked usingany tracking system suitable for use in a surgical environment, such as,for example, an optical, magnetic, radio, or acoustic tracking system,including the tracking system 40 described below.

In addition to the position sensors, the arm 33 may include redundantsensors (not shown). The redundant sensors are similar to the positionsensors and may be used to detect discrepancies and/or instabilityduring operation of the haptic device 30. For example, differences inoutput of the redundant sensors and output of the position sensors mayindicate a problem with the drive system and/or the position sensors.Redundant sensors can also improve accuracy in determining the pose ofthe arm 33 by providing data that enables a control system of the hapticdevice 30 to reduce or eliminate the effect of deflection in componentsof the drive system and/or the arm 33. The redundant sensors areparticularly advantageous when the arm 33 includes a cable transmission.

The end effector 35 comprises a working end of the haptic device 30 andis configured to enable the user to perform various activities relatedto a surgical procedure. For example, in one embodiment, the endeffector 35 functions as an adapter or coupling between the arm 33 andthe tool 50. By interchanging one tool 50 for another, the user canutilize the haptic device 30 for different activities, such asregistration, bone preparation, measurement/verification, and/or implantinstallation. In one embodiment, as shown in FIG. 2A, the end effector35 includes a proximal portion adapted to be connected to the arm 33 anda distal portion that includes a device or tool 50. The tool 50 may be,for example, a surgical tool (such as a burr, drill, probe, saw, etc.),medical device, microscope, laser range finder, camera, light,endoscope, ultrasound probe, irrigation device, suction device,radiotherapy device, and/or any other component useful for surgery,surgical planning, and/or surgical navigation. The end effector 35 ispreferably configured to removably engage the tool 50 so that the usercan install the appropriate tool 50 for a particular procedure andinterchange tools as necessary. For example, the tool 50 may be securedto the end effector 35 with conventional hardware (e.g., screws, pins,clamps, etc.), a keyed connection, detents, threaded connectors, aninterference fit, and the like. Alternatively, the tool 50 may be anintegral part of the end effector 35 so that the entire end effector 35is replaced when the user desires to interchange tools. The tool 50 ispreferably moveable with respect to the arm 33 to enable the user tocontrol a precise position of the tool 50. For example, the tool 50 maybe rotatable about an axis C-C (shown in FIG. 2C). In one embodiment, asshown in FIG. 3, the tool 50 includes a tool holder 51 received in anaperture 52 in the distal portion of the end effector 35. The toolholder 51 may be secured in the aperture in any known manner, such as,for example, with keyed or threaded connection. The tool holder 51 isconfigured to releasably engage the tool 50 (e.g., a tip of a sphericalburr) and may include a power line (not shown) for supplying electrical(or pneumatic) power to the tool 50. In one embodiment, the tool holder51 includes a motor for driving the tool 50 (e.g., a burr, saw, or otherpower tool). The tool 50 may be a single tool or may include multipletools. For example, the tool 50 may comprise a spherical burr for bonecutting as well as suction and irrigation lines for cleaning thesurgical site during a cutting operation. In one embodiment, the tool 50and the tool holder 51 comprise an electric, air cooled surgical toolcurrently manufactured by ANSPACH® and having product numbers EMAX2(motor), EMAX2-FP (foot pedal), SC2000 (console), L-2SB (2 mm flutedball), L-4B (4 mm fluted ball), L-6B (6 mm fluted ball), and L-1R (12)(1.2 mm×12.8 mm fluted router). The end effector 35 is mechanically andelectrically connected to the distal end of the arm 33 in anyconventional manner and may include one or more lines for supplyingpower, compressed air, suction, irrigation, and the like to the tool 50.

The end effector 35 may also be configured to enable the user to inputinformation into the surgical system 10. For example, in one embodiment,the end effector 35 is adapted to function as an input device, such as ajoystick. In this embodiment, the end effector 35 includes one or moredegrees of freedom to enable joystick functionality. As shown in FIG. 3,the end effector 35 may have a single degree of freedom that permits theend effector 35 to rotate about an axis A-A. Thus, the user can rotate(or twist) the end effector 35 about the axis A-A to provide input tothe surgical system 10. When the user rotates the end effector 35, acorresponding encoder signal indicating an amount and direction ofrotation may be relayed to the computer 21 and/or the computer 31. Forexample, rotation in a first direction about the axis A-A by a specifiednumber of degrees could indicate “forward” (e.g., proceed to anotherstep in the procedure or to another application, advance a screen on thedisplay device 23 to a subsequent screen, etc.), and rotation in asecond direction about the axis A-A by a specified number of degreescould indicate “back” (e.g., return to a previous step in the procedureor to another application, go back to a previous screen on the displaydevice 23, etc.). The end effector 35 (and/or other part of the arm 33)may also include additional degrees of freedom enabling additionalinput. In addition to joystick functionality, the end effector 35(and/or any other portion of the haptic device 30) may include one ormore buttons, dials, and/or switches to enable input. In this manner,efficiency and ease of use of the surgical system 10 is improved byproviding a convenient input mechanism for the user.

The user interface 37 of the haptic device 30 enables physicalinteraction between the user and the haptic device 30. For example, theinterface 37 may be configured so that the user can physically contactthe interface 37 and manipulate the tool 50 while simultaneouslyreceiving haptic guidance from the haptic device 30. The interface 37may be a separate component affixed to the haptic device 30 (such as ahandle or hand grip) or may simply be part of the existing structure ofthe haptic device 30. For example, the interface 37 may be associatedwith the arm 33, the end effector 35, and/or the tool 50. Because theinterface 37 is affixed to or is an integral part of the haptic device30, any tactile or force feedback output by the haptic device 30 istransmitted directly to the user when the user is in contact with theinterface 37. In one embodiment, as shown in FIG. 2A, the user interface37 comprises a first part (e.g., the elbow joint 33 e of the arm 33)configured to enable the user to change a configuration of the arm 33and a second part (e.g., the tool 50 and/or a distal end of the arm 33such as the end effector 35) configured to enable the user to move thetool 50 relative to the arm 33. In operation, as shown in FIG. 2C, auser 160 places one hand on the first part (e.g., the elbow joint 33 e)and grasps the second part (e.g., the tool 50) with the other hand. Theuser 160 then exerts force as needed to manipulate the arm 33 and movethe tool 50. In this manner, the user manipulates the interface 37 tosimultaneously change a configuration of the arm 33 and move the tool 50relative to the arm 33. Contacting the haptic device 30 in duallocations (e.g., the tool 50 and the elbow joint 33 e) advantageouslyallows both gross and fine control of the haptic device 30. For example,the user 160 is able to simultaneously control both a grossconfiguration of the arm 33 (e.g., via the elbow joint 33 e) and a fine(or precise) location of a tip of the tool 50 (e.g., by moving the tool50 relative to the arm 33), which is important in performing activitiesrequiring a high degree of accuracy and dexterity, such as, for example,maneuvering the tool 50 to the surgical site and sculpting bone.

The user interface 37 is preferably sized so that the user can easilygrip the interface 37. For example, a diameter of the interface 37 maycorrespond to a diameter that is easily grasped by a hand and/orfinger(s) of a user. The diameter of the interface 37 may be, forexample, in a range of approximately 5 mm to approximately 75 mm. In oneembodiment, the user interface 37 is integral with the end effector 35.In this embodiment, the end effector 35 includes one or more portionshaving a diameter suitable for gripping by the user. For example, adiameter of the proximal portion of the end effector 35 may be about 43mm; a diameter of the distal portion of the end effector 35 may be about36 mm; a diameter of the tool holder 51 may be about 19 mm; and adiameter of the tool 50 may be about 6 mm. In one embodiment, the distalportion of the end effector 35 includes a grip for the user's indexfinger. The interface 37 may optionally include a taper to accommodateusers with different hand sizes. The interface 37 may also be shaped orcontoured to mate with the contours of a user's hand and/or finger(s)and may include other ergonomic features, for example, to increase usercomfort and prevent slippage (e.g., when the user's glove iswet/bloody).

One advantage of the haptic device 30 is that the user interface 37advantageously enables the haptic device 30 to hold the tool 50cooperatively with the user. In contrast, haptic devices used insurgical teleoperation systems have a “slave” device that exclusivelyholds the tool and a “master” device through which the surgeon controlsthe tool. The master device is typically remote from the surgical siteeither to permit the surgeon to perform the surgery over a distance orto provide a more ergonomic working position/environment for thesurgeon. Thus, with a haptic teleoperation system, the surgeon has thedisadvantage of having to rely entirely on the teleoperation system toview the surgical site and perform the surgery. In contrast, with thesurgical system 10, as user moves the tool 50 with guidance from thehaptic device 30, the user remains in close physical and visualproximity to the surgical site.

Another advantage of the haptic device 30 is that the haptic device 30is not intended to move autonomously on its own. In contrast, autonomoussurgical robotic systems used for orthopedic joint replacement performbone cutting autonomously with a high speed burr. Although the surgeonmonitors progress of the robot and may interrupt if necessary, thesurgeon is not in full control of the procedure. With the haptic device30, however, the surgeon (as opposed to the robot) manipulates the tool50. Thus, the surgeon maintains control of the cutting operation andreceives only guidance or assistance from the haptic device 30. As aresult, the surgeon is not required to cede control to the robot of thehaptic device 30, which increases the surgeon's comfort level during theprocedure.

As described above in connection with the computing system 20, thehaptic device 30 may include the computer 31. The computer 31 may behoused in any convenient location on the surgical system 10, such as,for example, on or in a stand or equipment cabinet (e.g., the platform39 as shown in FIG. 1) on which the haptic device 30 is disposed. Thecomputer 31 may be used in addition to or as an alternative to thecomputer 21 of the computing system 20. The haptic device 30 (includingthe computer 31) may also include any other computer, electronic, orelectro-mechanical component suitable for use in a robotic and/or hapticdevice, such as, for example, a controller for receiving informationfrom the encoders and redundant sensors on the arm 33, amplifiers forproviding power to the motors, clutches, brakes, a power supply forfailsafe brakes, and/or a mode switch for placing the haptic device 30in a desired operational mode (e.g., approach mode, haptic mode, freemode, input mode, hold mode).

The haptic device 30 is preferably sized so that the haptic device 30can fit in an operating room without impeding other equipment ormovement of the user about the operating room. For example, in oneembodiment, a height of the haptic device 30 (with the arm 33 in astored or retracted position) is approximately 1.4 m, and a footprint ofthe haptic device 30 is in a range of between about 0.25 m² to about 0.6m². In another embodiment, the footprint is in a range of between about0.09 m² and 0.13 m². Similarly, the haptic device 30 preferably has aweight that enables the haptic device 30 to be moved from one locationto another with relative ease. For example, in one embodiment, theweight of the haptic device 30 is in a range of approximately 100 poundsto approximately 500 lbs. In another embodiment, the weight of thehaptic device 30 is in a range of approximately 50 pounds toapproximately 200 lbs. The haptic device 30 preferably has a low weightand small size both for ease of mobility and to permit the haptic device30 to be optimally positioned for the surgical procedure. For example,the haptic device 30 (or any portion thereof) may be configured to reston a floor of an operating room, to be mounted on the operating table(or other piece of equipment in the operating room), or to be affixed toa bone of the patient.

As shown in FIG. 1, the haptic device 30 (or a portion thereof, such asthe robot) may be mounted on a platform 39. The platform 39 may be anyknown platform, cart, or equipment stand, may include equipment racksand/or cabinets (e.g., to house the computer 31), and is preferablyconfigured to facilitate mobility of the haptic device 30. For example,the platform 39 may include rolling members 38 (e.g., wheels or casters)to enable the platform 39 to be moved. The platform 39 may also includea mechanism for securing the platform 39 in position. For example, theplatform 39 may be equipped with wheel locks or brakes for the rollingmembers 38, a foot pedal locking device, jack stands, and/or any otherknown mechanism for securing a platform or cart in position. In oneembodiment, as shown in FIG. 2A, the platform 39 includes rigid feet 39a that can be actuated between a retracted position (shown in FIG. 2A)and an extended position (not shown) with a mechanism 39 b. To move theplatform 39 from one location to another, the rigid feet 39 a areretracted so that the platform 39 can travel on the rolling members 38.To secure the platform 39 in position, the rigid feet 39 a are extendedso that the platform 39 rests on the rigid feet 39 a. Alternatively, therigid feet 39 a could be fixed on the platform 39, and the rollingmembers 38 could be extendable/retractable. Thus, the platform 39enables the haptic device 30 to be moved from one location to another,positioned as necessary for each surgical case, and secured in a desiredposition during storage and surgery. Alternatively, the haptic device 30(in whole or in part) may be installed in a room where a surgicalprocedure will be performed (e.g., mounted on a floor, wall, orworkstation), integrated with the computing system 20, integrated withan imaging device (e.g., a CT device, a fluoroscopic device, anultrasound device, etc.), and/or integrated with a medical system (e.g.,a medical equipment cart in a room where a surgical procedure will beperformed).

As shown in FIG. 1, the haptic device 30 and the computing system 20 arepreferably configured as separate units. Alternatively, the hapticdevice 30 (in whole or in part) and the computing system 20 (in whole orin part) may be integrated into a single unit. The haptic device 30 andthe computing system 20 (or portions thereof) may also be integratedwith other pieces of equipment, such as, for example, an imaging device(e.g., a CT device, an MRI device, a fluoroscopic device, an ultrasounddevice, etc.) and/or a hospital system (e.g., an equipment cart in aroom where the surgical procedure will be performed). In one embodiment,the computer 21 and the computer 31 are disposed on the platform 39 ofthe haptic device 30, and the display device 23 and the input device 25of the computing system 20 are disposed on a light weight stand tofacilitate the user's ability to view information from and inputinformation to the surgical system 10.

The tracking (or localizing) system 40 of the surgical system 10 isconfigured to determine a pose (i.e., position and orientation) of oneor more objects during a surgical procedure to detect movement of theobject(s). For example, the tracking system 40 may include a detectiondevice that obtains a pose of an object with respect to a coordinateframe of reference of the detection device. As the object moves in thecoordinate frame of reference, the detection device tracks the pose ofthe object to detect (or enable the surgical system 10 to determine)movement of the object. As a result, the computing system 20 can adjustthe control parameters (e.g., by adjusting a virtual object) in responseto movement of the tracked object. Tracked objects may include, forexample, tools/instruments, patient anatomy, implants/prostheticdevices, and components of the surgical system 10. Using pose data fromthe tracking system 40, the surgical system 10 is also able to register(or map or associate) coordinates in one space to those in another toachieve spatial alignment or correspondence (e.g., using a coordinatetransformation process as is well known). Objects in physical space maybe registered to any suitable coordinate system, such as a coordinatesystem being used by a process running on the computer 21 and/or thecomputer 31. For example, utilizing pose data from the tracking system40, the surgical system 10 is able to associate the physical anatomy andthe tool 50 (and/or the haptic device 30) with a representation of theanatomy (such as an image displayed on the display device 23). Based ontracked object and registration data, the surgical system 10 maydetermine, for example, (a) a spatial relationship between the image ofthe anatomy and the relevant anatomy and (b) a spatial relationshipbetween the relevant anatomy and the tool 50 so that the computingsystem 20 can superimpose (and continually update) a virtualrepresentation of the tool 50 on the image, where the relationshipbetween the virtual representation and the image is substantiallyidentical to the relationship between the tool 50 and the actualanatomy. Additionally, by tracking not only the tool 50 but also therelevant anatomy, the surgical system 10 can compensate for movement ofthe relevant anatomy during the surgical procedure (e.g., by adjusting avirtual object in response to the detected movement).

Registration may include any known registration technique, such as, forexample, image-to-image registration (e.g., monomodal registration whereimages of the same type or modality, such as fluoroscopic images or MRimages, are registered and/or multimodal registration where images ofdifferent types or modalities, such as MM and CT, are registered);image-to-physical space registration (e.g., image-to-patientregistration where a digital data set of a patient's anatomy obtained byconventional imaging techniques is registered with the patient's actualanatomy); and/or combined image-to-image and image-to-physical-spaceregistration (e.g., registration of preoperative CT and MRI images to anintraoperative scene).

The tracking system 40 may be any tracking system that enables thesurgical system 10 to continually determine (or track) a pose of therelevant anatomy of the patient and a pose of the tool 50 (and/or thehaptic device 30). For example, the tracking system 40 may comprise anon-mechanical tracking system, a mechanical tracking system, or anycombination of non-mechanical and mechanical tracking systems suitablefor use in a surgical environment. The non-mechanical tracking systemmay include an optical (or visual), magnetic, radio, or acoustictracking system. Such systems typically include a detection deviceadapted to locate in predefined coordinate space specially recognizabletrackable elements (or trackers) that are detectable by the detectiondevice and that are either configured to be attached to the object to betracked or are an inherent part of the object to be tracked. Forexample, the a trackable element may include an array of markers havinga unique geometric arrangement and a known geometric relationship to thetracked object when the trackable element is attached to the trackedobject. The known geometric relationship may be, for example, apredefined geometric relationship between the trackable element and anendpoint and axis of the tracked object. Thus, the detection device canrecognize a particular tracked object, at least in part, from thegeometry of the markers (if unique), an orientation of the axis, and alocation of the endpoint within a frame of reference deduced frompositions of the markers. The markers may include any known marker, suchas, for example, extrinsic markers (or fiducials) and/or intrinsicfeatures of the tracked object. Extrinsic markers are artificial objectsthat are attached to the patient (e.g., markers affixed to skin, markersimplanted in bone, stereotactic frames, etc.) and are designed to bevisible to and accurately detectable by the detection device. Intrinsicfeatures are salient and accurately locatable portions of the trackedobject that are sufficiently defined and identifiable to function asrecognizable markers (e.g., landmarks, outlines of anatomical structure,shapes, colors, or any other sufficiently recognizable visualindicator). The markers may be located using any suitable detectionmethod, such as, for example, optical, electromagnetic, radio, oracoustic methods as are well known. For example, an optical trackingsystem having a stationary stereo camera pair sensitive to infraredradiation may be used to track markers that emit infrared radiationeither actively (such as a light emitting diode or LED) or passively(such as a spherical marker with a surface that reflects infraredradiation). Similarly, a magnetic tracking system may include astationary field generator that emits a spatially varying magnetic fieldsensed by small coils integrated into the tracked object.

In one embodiment, as shown in FIG. 1, the tracking system 40 includes anon-mechanical tracking system. In this embodiment, the non-mechanicaltracking system is an optical tracking system that comprises a detectiondevice 41 and at least one trackable element (or tracker) configured tobe disposed on (or incorporated into) a tracked object and detected bythe detection device 41. As shown in FIG. 1, the detection device 41 mayinclude, for example, a stereo camera pair sensitive to infraredradiation and positionable in an operating room where the surgicalprocedure will be performed. The tracker is configured to be affixed tothe tracked object in a secure and stable manner and includes an arrayof markers (e.g., an array S1 in FIG. 4) having a known geometricrelationship to the tracked object. The markers may be active (e.g.,light emitting diodes or LEDs) or passive (e.g., reflective spheres, acheckerboard pattern, etc.) and preferably have a unique geometry (e.g.,a unique geometric arrangement of the markers) or, in the case ofactive, wired markers, a unique firing pattern. In operation, thedetection device 41 detects positions of the markers, and the uniquegeometry (or firing pattern) and known geometric relationship to thetracked object enable the surgical system 10 to calculate a pose of thetracked object based on the positions of the markers.

Because the non-mechanical tracking system relies on an ability of thedetection device 41 to optically “see” the markers, the detection device41 and the tracker should be positioned so that a clear line of sightbetween the detection device 41 and the markers is maintained during thesurgical procedure. As a safeguard, the surgical system 10 is preferablyconfigured to alert a user if the detection device 41 is unable todetect the tracker during the procedure (e.g., when the line of sightbetween the detection device 41 and one or more of the markers isblocked and/or when reflectivity of the markers is occluded). Forexample, the surgical system 10 may include an audible (and/or visual)alarm programmed to sound (and/or flash) when a person steps between themarkers and the detection device 41, when an object is interposedbetween the markers and the detection device 41, when a lens of thecamera is occluded (e.g., by dust), and/or when reflectivity of themarkers is occluded (e.g., by blood, tissue, dust, bone debris, etc.).The surgical system 10 may also include programming to trigger othersafety features, such as, for example, an occlusion detection algorithm(discussed below in connection with step S11 of FIG. 13) with a powershutoff feature that disables the tool 50 when the detection device 41loses sight of the markers.

The non-mechanical tracking system may include a trackable element (ortracker) for each object the user desires to track. For example, in oneembodiment, the non-mechanical tracking system includes an anatomytracker 43 (to track patient anatomy), a haptic device tracker 45 (totrack a global or gross position of the haptic device 30), an endeffector tracker 47 (to track a distal end of the haptic device 30), andan instrument tracker 49 (to track an instrument/tool held manually bythe user).

As shown in FIG. 1, the anatomy tracker 43 is disposed on a relevantportion of a patient's anatomy (such as a bone) and is adapted to enablethe relevant anatomy to be tracked by the detection device 41. Theanatomy tracker 43 includes a fixation device for attachment to theanatomy. The fixation device may be, for example, a bone pin, surgicalstaple, screw, clamp, wearable device, intramedullary rod, or the like.In one embodiment, the anatomy tracker 43 is configured for use duringknee replacement surgery to track a femur F and a tibia T of a patient.In this embodiment, as shown in FIG. 1, the anatomy tracker 43 includesa first tracker 43 a adapted to be disposed on the femur F and a secondtracker 43 b adapted to be disposed on the tibia T. As shown in FIG. 4,the first tracker 43 a includes a fixation device comprising bone pins Pand a unique array S1 of markers (e.g., reflective spheres). The arrayS1 is affixed to a connection mechanism 400 that is adapted to beremovably secured to both of the bone pins P. For example, as shown inFIG. 4, the connection mechanism 400 may include a first portion 442, asecond portion 444, and screws 445. To install the first tracker 43 a onthe femur F, the user screws the bone pins P into the femur F, slidesthe connection mechanism 400 over the bone pins P, and tightens thescrews 445 to draw the first and second portions 442 and 444 together tothereby securely fix the connection mechanism 400 to the bone pins P.Once secured, the connection mechanism 400 imparts additional stabilityto the bone pins P. The second tracker 43 b is identical to the firsttracker 43 a except the second tracker 43 b is installed on the tibia Tand has its own unique array of markers. When installed on the patient,the first and second trackers 43 a and 43 b enable the detection device41 to track motion of the femur F and the tibia T during kneereplacement surgery. As a result, the surgical system 10 is able tocompensate for bone motion in real-time during surgery.

As shown in FIG. 2A, the haptic device tracker 45 is disposed on thehaptic device 30 and is adapted to enable the surgical system 10 tomonitor a global or gross position of the haptic device 30 in physicalspace. In particular, the haptic device tracker 45 enables the surgicalsystem 10 to determine whether the haptic device 30 has moved relativeto other objects in the surgical environment, such as the patient. Suchinformation is important because the tool 50 is attached to the hapticdevice 30. For example, if the user intentionally repositions orinadvertently bumps the haptic device 30 while cutting the femur F withthe tool 50, the tracking system 40 will detect movement of the hapticdevice tracker 45. In response, the surgical system 10 can makeappropriate adjustments to programs running on the computer 21 and/orthe computer 31 to compensate for global or gross movement of the hapticdevice 30 (and the attached tool 50) relative to the femur F. As aresult, integrity of the femur preparation process is maintained.

As shown in FIGS. 2A and 5, the haptic device tracker 45 includes aunique array S3 of markers (e.g., reflective spheres) and is adapted tobe mounted on the base 32 of the haptic device 30. The haptic devicetracker 45 is preferably mounted so that the haptic device tracker 45can be secured in a fixed position relative to the base 32. The fixedposition is calibrated to the haptic device 30 (as discussed below inconnection with step S9 of FIG. 13) so that the surgical system 10 knowswhere the haptic device tracker 45 is located with respect to the base32 of the haptic device 30. Once calibrated, the fixed position ismaintained during the surgical procedure. In one embodiment, as shown inFIGS. 2A and 5, the haptic device tracker 45 includes an arm 34 having aproximal end connected to the base 32 (e.g., via screws, rivets,welding, clamps, magnets, etc.) and a distal end that carries the arrayS3 of markers. The arm 34 may include one or more support members (e.g.,brackets, struts, links, etc.) having a rigid structure so that thehaptic device tracker 45 is fixed in a permanent position with respectto the haptic device 30. Preferably, however, the arm 34 is adapted foradjustability so that the array S3 is moveable between a first positionand a second position relative to the haptic device 30. Thus, the arrayS3 may be positioned independently of the base 32 of the haptic device30 before being secured in a fixed position. One advantage ofadjustability is that a position of the array S3 may be customized foreach surgical case (e.g., based on patient size, operating table height,etc.). Another advantage of adjustability is that the array S3 may bepositioned so as not to impede the user during a surgical procedure.Adjustability may be imparted to the arm 34 in any known manner (e.g.,an articulating arm, a flexible neck, etc.). For example, in oneembodiment, as shown in FIG. 5, the arm 34 includes a ball joint 34 b onwhich the haptic device tracker 45 is disposed. The ball joint 34 bincludes a locking mechanism actuated by a handle 34 a. In operation,the user may unscrew the handle 34 a to release the ball joint 34 b,manipulate the ball joint 34 b until the haptic device tracker 45 is ina desired position, and tighten the handle 34 a until the ball joint 34b is fixedly secured. In this manner, the haptic device tracker 45 maybe fixed in the desired position. As an alternative to securing thehaptic device tracker 45 in a fixed position and calibrating the fixedposition to the haptic device 30, the arm 34 may include positionsensors (e.g., encoders). The position sensors may be similar to theposition sensors of the arm 33 and may operate in conjunction withappropriate software (e.g., software running on the computer 21 or thecomputer 31) to provide measurements of a pose of the arm 34 relative tothe base 32. When position sensors are incorporated into the arm 34, thecalibration process of step S11 below may be eliminated because thesurgical system 10 can determine the location of the haptic devicetracker 45 with respect to the base 32 based on the pose of the arm 34provided by the position sensors.

The end effector tracker 47 is adapted to enable the surgical system 10to determine a pose of a distal end (e.g., a working end) of the hapticdevice 30. The end effector tracker 37 is preferably configured to bedisposed on a distal end of the arm 33 or on the tool 50. For example,as shown in FIG. 6B, the end effector tracker 47 may be disposed on theend effector 35. As shown in FIG. 6A, the end effector tracker 47 mayinclude a unique array S4 of markers (e.g., reflective spheres) and maybe adapted to be affixed to the end effector 35 in any known manner,such as, for example, with a clamping device, threaded connection,magnet, or the like. As shown in FIG. 6A, in one embodiment, the endeffector tracker 47 is affixed to the end effector 35 with a clamp 1500.The clamp 1500 may be formed integrally with the array S4 or affixed tothe array S4 in any conventional manner, such as with mechanicalhardware, adhesive, welding, and the like. The clamp 1500 includes afirst portion 1505, a second portion 1510, and a thumbscrew 1515. Thefirst and second portions 1505 and 1510 are shaped to receive a portionof the end effector, such as a cylindrical portion of the tool 50 or thetool holder 51. For example, as shown in FIG. 6A, the first portion 1505may have a planar surface and the second portion 1510 may have aV-shaped groove so that the first and second portions 1505 and 1510 cansecurely receive the tool 50 or the tool holder 51 when tightenedtogether. To install the end effector tracker 47 on the end effector 35,the first and second portions 1505 and 1515 of the clamp 1500 aredisposed around the tool 50 or the tool holder 51 and tightened togetherusing the thumbscrew 1515. The end effector tracker 47 may also includea feature to aid in properly orienting the end effector tracker 47 wheninstalling the end effector tracker 47 on the haptic device 30. Forexample, the end effector tracker 47 may include a divot 47 a as shownin FIG. 6B.

In one embodiment, the end effector tracker 47 is used only duringcalibration of the haptic device 30 (as discussed below in connectionwith step S9 of FIG. 13) and is removed prior to performance of thesurgical procedure. In this embodiment, the end effector tracker 47 isdisposed on the end effector 35 (as shown in FIG. 6B) and the hapticdevice tracker 45 is mounted to the base 32 of the haptic device 30(e.g., via the adjustable arm 34 as shown in FIG. 2A) so that a positionof the haptic device tracker 45 with respect to the haptic device 30 isadjustable. Because the position of the haptic device tracker 45 isadjustable (as opposed to permanently fixed), the surgical system 10does not know the location of the haptic device tracker 45 with respectto the haptic device 30. To determine the geometric relationship betweenthe haptic device 30 and the haptic device tracker 45, the calibrationprocess utilizes the end effector tracker 47. Although the end effectortracker 47 may remain on the haptic device 30 for the entire surgicalprocedure (or any portion thereof), it is advantageous to remove the endeffector tracker 47 when the calibration process is complete. Forexample, the user may desire to remove the end effector tracker 47 toprevent the tracker 47 from interfering with the user's grip on thehaptic device 30, the patient's anatomy, medical instruments andequipment, and/or other personnel in the operating room. Anotheradvantage of removing the end effector tracker 47 is that movement ofthe end effector tracker 47 during the surgical procedure may result indegraded performance of the surgical system 10 due to delays or limitedbandwidth as the tracking system 40 measures the movement end effectortracker 47.

In an alternative embodiment, the end effector tracker 47 may beeliminated. In this embodiment, the haptic device tracker 45 is fixed ina permanent position on the haptic device 30. Because the haptic devicetracker 45 is fixed in a permanent position on the haptic device 30, therelationship between the haptic device tracker 45 and the coordinateframe of the haptic device 30 is known. Accordingly, the surgical system10 does not need the end effector tracker 47 for calibration toestablish a relationship between the haptic device tracker 45 and thecoordinate frame of the haptic device 30. In this embodiment, the hapticdevice tracker 45 may be rigidly mounted on the haptic device 30 in anyposition that permits the tracking system 40 to see the array S3 of thehaptic device tracker 45, that is close enough to the surgical site soas not to degrade accuracy, and that will not hinder the user orinterfere with other personnel or objects in the surgical environment.

In another alternative embodiment, the haptic device 30 is firmly lockedin position. For example, the haptic device 30 may be bolted to a floorof the operating room or otherwise fixed in place. As a result, theglobal or gross position of the haptic device 30 does not changesubstantially so the surgical system 10 does not need to track theglobal or gross position of the haptic device 30. Thus, the hapticdevice tracker 45 may be eliminated. In this embodiment, the endeffector tracker 47 may be used to determine an initial position of thehaptic device 30 after the haptic device 30 is locked in place.

In another alternative embodiment, the tracking system 40 is attached tothe haptic device 30 in a permanently fixed position. For example, thetracking system 40 (including the detection device 41) may be mounteddirectly on the haptic device 30 or connected to the haptic device 30via a rigid mounting arm or bracket so that the tracking system is fixedin position with respect to the haptic device 30. In this embodiment,the haptic device tracker 45 and the end effector tracker 47 may beeliminated because a position of the tracking system 40 relative to thehaptic device 30 is fixed and may be established during a calibrationprocedure performed, for example, during manufacture or set up of thehaptic device 30.

In another alternative embodiment, the tracking system 40 is attached tothe haptic device 30 in an adjustable manner. For example, the trackingsystem 40 (including the detection device 41) may be connected to thehaptic device 30 with an arm, such as the adjustable arm 34 (describedabove in connection with the haptic device tracker 45) so that thetracking system 40 is moveable from a first position to a secondposition relative to the haptic device 30. After the arm and thetracking system 40 are locked in place, a calibration can be performedto determine a position of the tracking system 40 relative to the hapticdevice 30. The calibration may be performed, for example, using the endeffector tracker 47.

The instrument tracker 49 is adapted to be coupled to an instrument 150that is held manually in the hand of the user (as opposed, for example,to the tool 50 that is attached to the end effector 35). The instrument150 may be, for example, a probe, such as a registration probe (e.g., astraight or hooked probe). As shown in FIG. 7, the instrument tracker 49may comprise a unique array S5 of markers (e.g., reflective spheres)formed integrally with the instrument 150 or affixed to the instrument150 in any known manner, such as with mechanical hardware, adhesive,welding, a threaded connection, a clamping device, a clip, or the like.When the instrument tracker 49 is removably connected to the instrument150, such as with a clip or a clamping device, the instrument tracker 49should be calibrated to the instrument 150 to determine a relationshipbetween the instrument tracker 49 and a geometry of the instrument 150.Calibration may be accomplished in any suitable manner, such as with atool calibrator having a divot or a V-groove (e.g., as described in U.S.Patent Application Pub. No. US 2003/0209096, which is herebyincorporated by reference herein in its entirety). One advantage ofusing a clip or clamping device (such as the clamp 1500 shown in FIG.6A) to connect the tracker 49 to the instrument 150 is that the clip orclamping device may be adjustable to fit various sizes of instruments.Thus, a single clip or clamping device may be used with multipleinstruments. Knowing a geometric relationship between the array S5 andthe instrument 150, the surgical system 10 is able to calculate aposition of a tip of the instrument 150 in physical space. Thus, theinstrument 150 can be used to register an object by touching a tip ofthe instrument 150 to a relevant portion of the object. For example, theinstrument 150 may be used to register a bone of the patient by touchinglandmarks on the bone or points on a surface of the bone. The instrument150 may also be used to verify proper alignment of an implant installedin the patient by touching the tip of the instrument 150 to predefinedverification features (e.g., divots) located on the implant.

The instrument tracker 49 may also be configured to verify calibrationof the instrument 150. For example, another tracker (e.g., the tracker43, 45, or 47) may include a divot into which the user can insert thetip of the instrument 150. In one embodiment, as shown in FIG. 6B, theend effector tracker 47 includes a divot 47 a into which the user caninsert the tip of the instrument 150. The detection device 41 can thenacquire pose data for the instrument tracker 49 and the end effectortracker 47, and the surgical system 10 can compare an actual geometricrelationship between the trackers 47 and 49 to an expected geometricrelationship. Deviation between the actual and expected geometricrelationships indicates that a physical parameter (e.g., straightness,tip position, etc.) of the instrument 150 is out of calibration. Asshown in FIG. 29, during the verification process, the surgical system10 may display a screen showing a graphical representation of theinstrument 150, the instrument tracker 49, and the end effector tracker47 on the display device 23.

The tracking system 40 may additionally or alternatively include amechanical tracking system. In contrast to the non-mechanical trackingsystem (which includes a detection device 41 that is remote from thetrackers 43, 45, 47, and 49), a mechanical tracking system may beconfigured to include a detection device (e.g., an articulating armhaving joint encoders) that is mechanically linked (i.e., physicallyconnected) to the tracked object. The tracking system 40 may include anyknown mechanical tracking system, such as, for example, a mechanicaltracking system as described in U.S. Pat. No. 6,033,415 and/or U.S. Pat.No. 6,322,567, each of which is hereby incorporated by reference hereinin its entirety. In one embodiment, the tracking system 40 includes amechanical tracking system having a jointed mechanical arm 241 (e.g., anarticulated arm having six or more degrees of freedom) adapted to tracka bone of the patient. As shown in FIG. 8, the arm 241 has a proximalend affixed to the base 32 of the haptic device 30 and a freely moveabledistal end fixed to the femur F of the patient. Alternatively, theproximal end may be affixed to any other suitable location (such as, forexample, to a rail of an operating table, a leg holder, etc.) but ispreferably connected (e.g., directly or via a bracket) to the base 32 ofthe haptic device 30 so that the arm 241 moves globally with the hapticdevice 30. The distal end of the arm 241 includes an fixation device 245adapted for rigid fixation to the femur F, such as, for example, a bonepin, bone screw, clamp, wearable device, surgical staple, or the like.The arm 241 is configured to have multiple degrees of freedom. Forexample, in one embodiment, as shown in FIG. 8, the arm 241 includes aplurality of links 242 connected at joints 244. Each joint 244incorporates one or more position sensors (not shown) to track a pose ofthe arm 241. The position sensors may include any suitable sensor, suchas, for example, the position sensors described above in connection withthe arm 33 of the haptic device 30. In operation, as the femur F moves,the distal end of the arm travels with the femur F. The position sensors(and appropriate software) produce measurements of a pose of the distalend of the arm relative to the proximal end of the arm fixed to thehaptic device 30. In this manner, motion of the femur F relative to thehaptic device 30 is captured. The mechanical tracking system 240 mayalso include a second arm that is identical to the arm 241 but isrigidly affixed to the tibia T to enable the tracking system 240 totrack motion of the tibia T. In this manner, the mechanical trackingsystem 240 may be used to track the femur F and the tibia T so that thesurgical system 10 can detect bone motion in real time during surgery.Using bone motion data in conjunction with appropriate software, thesurgical system 10 can compensate for the bone motion in real timeduring surgery.

One advantage of the mechanical tracking system over a non-mechanicaltracking system is that the detection device (i.e., the arm 241) isphysically connected to the tracked object and therefore does notrequire a line of site to “see” markers on the tracked object. Thus, theuser and other personnel may freely move about the operating room duringa surgical procedure without worrying about blocking an invisible lineof sight between a set of markers and an optical camera. Anotheradvantage of the mechanical tracking system is that the arm 241 may bephysically connected to the haptic device 30 (e.g., to the base 32).Such a configuration eliminates the need to track a global or grossposition of the haptic device 30 relative to the patient (e.g., usingthe haptic device tracker 45 as described above). There is no need totrack the global or gross position of the haptic device 30 because thearm 241 moves with the haptic device 30. As a result, the haptic device30 may be repositioned during a procedure without having to berecalibrated to a bone motion tracking system. Additionally, mechanicaltracking systems may be more accurate than non-mechanical trackingsystems and may enable faster update rates to the computer 21 and/or thecomputer 31. Faster update rates are possible because a mechanicaltracking system is hardwired to the computer 21 and/or the computer 31.Thus, the update rate is limited only by the speed of the computer 21and/or the computer 31.

In an alternative embodiment, the arm 241 of the mechanical trackingsystem may be attached to an operating table, a leg holder 62 (e.g., asshown in FIG. 14A), or other structure in the surgical environment. Inthis embodiment, a calibration is performed to determine a pose of thearm 241 relative to the haptic device 30. For example, in oneembodiment, the calibration is performed by placing the distal end(e.g., the end effector 35) of haptic device 30 in a known geometricrelationship with the distal end of the arm 241. In another embodiment,the distal end of the arm 241 is placed in a known geometricrelationship with the base 32 of the haptic device 30. In yet anotherembodiment, the distal end (e.g., the end effector 35) of the hapticdevice 30 is brought into a known geometric relationship with a base ofthe arm 241.

When the tracking system 40 includes the mechanical tracking system, thearm 241 may be used to register the patient's anatomy. For example, theuser may use the arm 241 to register the tibia T while the second arm(i.e., the arm that is identical to the arm 241 but that is affixed tothe tibia T) tracks motion of the tibia T. Registration may beaccomplished, for example, by pointing a tip of the distal end of thearm 241 to anatomical landmarks on the tibia T and/or by touching pointson (or “painting”) a surface of the tibia T with the tip of the distalend of the arm 241. As the user touches landmarks on the tibia T and/orpaints a surface of the tibia T, the surgical system 10 acquires datafrom the position sensors in the arm 241 and determines a pose of thetip of the arm 241. Simultaneously, the second arm provides dataregarding motion of the tibia T so that the surgical system 10 canaccount for bone motion during registration. Based on the bone motiondata and knowledge of the position of the tip of the arm 241, thesurgical system 10 is able to register the tibia T to the diagnosticimages and/or the anatomical model of the patient's anatomy in thecomputing system 20. In a similar manner, the second arm may be used toregister the femur F while the arm 241 (which is affixed to the femur F)tracks motion of the femur F. The patient's anatomy may also beregistered, for example, using a non-mechanical tracking system incombination with a tracked probe (e.g., the instrument 150 with theinstrument tracker 49) and/or using the haptic device 30 (e.g., asdescribed below in connection with step S8 of FIG. 13).

As shown in FIG. 1, the tracking system 40 may be coupled to the hapticdevice 30 via an interface 100 b. The interface 100 b includes aphysical interface and a software interface. The physical interface maybe any known interface such as, for example, a wired interface (e.g.,serial, USB, Ethernet, CAN bus, and/or other cable communicationinterface) and/or a wireless interface (e.g., wireless Ethernet,wireless serial, infrared, and/or other wireless communication system).The software interface may be resident on the computer 21 and/or thecomputer 31 and enables the haptic device 30 and the computing system 20to communicate with and control operation of the tracking system 40.

The surgical system 10 is adapted to be connected to a power source. Thepower source may be any known power source, such as, for example, anelectrical outlet, a battery, a fuel cell, and/or a generator and may beconnected to the surgical system 10 using conventional hardware (e.g.,cords, cables, surge protectors, switches, battery backup/UPS, isolationtransformer, etc.). The surgical system 10 preferably includes auser-activated device for manually controlling a supply of power to thetool 50. For example, the surgical system 10 may include a foot pedal(or other switching device) that can be positioned on the floor of theoperating room in proximity to the user. Depressing the foot pedalcauses the power source to supply power to the tool 50 (or to acompressed air supply in the case of a pneumatic tool 50). Conversely,releasing the foot pedal disrupts the flow of power to the tool 50. Thesurgical system 10 may also be adapted to automatically disrupt the flowof power to the tool 50 to promote safety. For example, the surgicalsystem 10 may include programs or processes (e.g., running on thecomputer 21 and/or the computer 31) configured to shut off the tool 50if a dangerous condition is detected, such as, for example, when theanatomy tracker 43 and/or the haptic device tracker 45 become occludedduring a critical operation such as bone cutting.

In operation, the computing system 20, the haptic device 30, and thetracking system 40 cooperate to enable the surgical system 10 to providehaptic guidance to the user during a surgical procedure. The surgicalsystem 10 provides haptic guidance by simulating the human tactilesystem using a force feedback haptic interface (i.e., the haptic device30) to enable the user to interact with a virtual environment. Thehaptic device 30 generates computer controlled forces to convey to theuser a sense of natural feel of the virtual environment and virtual (orhaptic) objects within the virtual environment. The computer controlledforces are displayed (i.e., reflected or conveyed) to the user to makehim sense the tactile feel of the virtual objects. For example, as theuser manipulates the tool 50, the surgical system 10 determines theposition and orientation of the tool 50. Collisions between a virtualrepresentation of the tool 50 and virtual objects in the virtualenvironment are detected. If a collision occurs, the surgical system 10calculates haptic reaction forces based on a penetration depth of thevirtual tool into the virtual object. The calculated reaction forces aremapped over the virtual object surface and appropriate force vectors arefed back to the user through the haptic device 30. As used herein, theterm “virtual object” (or “haptic object”) can be used to refer todifferent objects. For example, the virtual object may be arepresentation of a physical object, such as an implant or surgicaltool. Alternatively, the virtual object may represent material to beremoved from the anatomy, material to be retained on the anatomy, and/oranatomy (or other objects) with which contact with the tool 50 is to beavoided. The virtual object may also represent a pathway, a guide wire,a boundary, a border, or other limit or demarcation.

To enable the user to interact with the virtual environment, thesurgical system 10 employs a haptic rendering process. One embodiment ofsuch a process is represented graphically in FIG. 40. In operation,position sensors (block 2502) of the haptic device 30 (block 2500)provide data to a forward kinematics process (block 2504). Output of theforward kinematics process is input to a coordinate transformationprocess (block 2506). A haptic rendering algorithm (block 2508) receivesdata from the coordinate transformation process and provides input to aforce mapping process (block 2510). Based on the results of the forcemapping process, actuators (block 2512) of the haptic device 30 areactuated to convey an appropriate haptic wrench (i.e., force and/ortorque) to the user. The position sensors of block 2502 and theactuators of block 2512 are described above in connection with the arm33 of the haptic device 30. The forward kinematics process of block 2504and the coordinate transform process of block 2506 are discussed belowin connection with step 5708 of FIG. 43. The haptic rendering algorithmof block 2508 and the force mapping process of block 2510 are discussedbelow in connection with FIG. 50.

The haptic rendering process may include any suitable haptic renderingprocess, such as, for example, a haptic rendering process as describedin U.S. Pat. No. 6,111,577; C. B. Zilles & J. K. Salisbury, Aconstraint-based god-object method for haptic display, Proceedings ofthe IEEE/RSJ International Conference on Intelligent Robots and Systems,Vol. 3, pp. 146-51, 1995; T. V. Thompson II, D. E. Johnson & E. Cohen,Direct haptic rendering of sculptured models, Proceedings of theSymposium on Interactive 3D Graphics, pp. 167-76, 1997; K. Salisbury &C. Tar, Haptic rendering of surfaces defined by implicit functions,Proceedings of the ASME Dynamic Systems and Control Division, DSC-Vol.61, pp. 61-67, 1997; and/or J. E. Colgate, M. C. Stanley & J. M. Brown,Issues in the haptic display of tool use, Proceedings of the IEEE/RSJInternational Conference on Intelligent Robots and Systems, Vol. 3, pp.140-45, 1995, each of which is hereby incorporated by reference hereinin its entirety.

The virtual environment created by the haptic rendering process includesvirtual (or haptic) objects that interact with a virtual representationof the tool 50. Interaction between the virtual objects and the virtualrepresentation of the tool 50 may be point-based or ray-based. In apreferred embodiment, the surgical system 10 employs point-based hapticinteraction where only a virtual point, or haptic interaction point(HIP), interacts with virtual objects in the virtual environment. TheHIP corresponds to a physical point on the haptic device 30, such as,for example, a tip of the tool 50. The HIP is coupled to the physicalpoint on the physical haptic device 30 by a virtual spring/damper model.The virtual object with which the HIP interacts may be, for example, ahaptic object 705 (shown in FIG. 42) having a surface 707 and a hapticforce normal vector F. A penetration depth d_(i) is a distance betweenthe HIP and the nearest point on the surface 707. The penetration depthd_(i) represents the depth of penetration of the HIP into the hapticobject 705.

The virtual (or haptic) objects can be modeled, for example, using 3Dgeometric primitive objects, 3D polygonal objects, mathematicalequations, computer models, surface models, and/or voxel arrays. Hapticobjects may be static, quasi-static, dynamic, continuous, discontinuous,time varying, and/or existing only at certain times. In one embodiment,the haptic object is modeled using one or more functions of toolposition, orientation, velocity, and/or acceleration. Thus, in the caseof a surgical bone cutting operation, the haptic rendering process mayproduce a mapping of output wrench versus tool position. The mapping maybe configured so that the output wrench fed back to the user issufficient to resist further penetration of the virtual tool (or HIP)into the haptic object. In this manner, a virtual cutting boundary isestablished. The virtual boundary is associated with (e.g., registeredto) the physical anatomy of the patient, an image of the anatomy, and/orother coordinate frame of interest. A haptic object rendered by thehaptic rendering process may function as a pathway (e.g., a guide wire),may be repulsive (e.g., configured to repel the tool 50 from entering aninterior of a haptic object), may function as a container (e.g., tomaintain the tool 50 within the interior of the haptic object), and/ormay have portions that repel and portions that contain. As shown in FIG.41, multiple haptic objects 701 may be superimposed so that forcevectors F from each of the haptic objects 701 are combined to yield aresultant haptic force vector F_(v). In one embodiment, the output fromeach haptic object 701 comprises a Cartesian force vector with respectto an inertial coordinate frame and having linear properties. Themaximum number of haptic objects may be determined based oncomputational costs.

A haptic object may be customized to include any desired shape, such as,for example, anatomically contoured implant shapes, protectiveboundaries for sensitive structures (e.g., intra-articular anatomy),image-derived tumor boundaries, and virtual fixtures for in vivoassembly of implant components. In one embodiment, the haptic object maybe uniquely contoured to match a disease state of the patient. Forexample, the haptic object may define a virtual cutting boundary thatencompasses only diseased bone. Thus, the haptic object can be used toguide the user in removing the diseased bone while sparing healthysurrounding bone. In this manner, the surgical system 10 enables theuser to sculpt bone in a customized manner, including complex geometriesand curves that are not possible with conventional cutting jigs and sawguides. As a result, the surgical system 10 facilitates bone sparingsurgical procedures and implant designs that are smaller in size andadapted for a patient's unique disease state.

A haptic object may have an associated spatial or geometricrepresentation that can be graphically represented on the display device23. The graphical representation may be selected so as to convey usefulinformation to the user. For example, as shown in FIG. 1, a hapticobject 300 configured assist the user in guiding the tool 50 to thesurgical site may be represented graphically as a funnel shaped volume.As a virtual tool corresponding to the physical tool 50 moves throughand interacts with the haptic object 300, haptic forces are reflected tothe user so that the tool 50 is directed to the surgical site.Alternatively, as shown in FIG. 9, a haptic object 310 may berepresented graphically as a guide wire. As the virtual tool moves alongand interacts with the haptic object 310, haptic forces are reflected tothe user so that the tool 50 is guided directly to the surgical site. Inone embodiment, a haptic object defining a virtual cutting boundary foran implant may be depicted on the display device 23 as a graphical imagehaving a shape that substantially corresponds to a shape of the implant.Thus, a haptic object 208 defining a virtual cutting boundary for afemoral component 72 (shown in FIG. 10A) may have a correspondinggraphical representation as shown in FIG. 9. Similarly, a haptic object206 defining a virtual cutting boundary for a tibial component 74 (shownin FIG. 10B) may have a corresponding graphical representation as shownin FIG. 9.

Haptic objects having simple volumes are preferably modeled with acombination of 3D implicit surface objects such as planes, spheres,cones, cylinders, etc. For example, the haptic object 705 shown in FIG.42 is a sphere. Surfaces of the haptic object 705 are continuouslysmooth, and solutions to the penetration depth d_(i) and the hapticforce normal vector F_(n) can be obtained at a non-expensive, fixedcomputational cost from compact mathematical surface functions based onthe haptic interaction point (HIP). For more complex objects, polygonbased haptic rendering techniques may be used.

FIG. 43 illustrates an embodiment of a polygon based haptic renderingprocess according to the present invention. In step S702, a virtualenvironment with which the user can interact is generated using, forexample, computer-aided design (CAD) software. The virtual environmentmay be created, for example, using an explicit surface model. In oneembodiment, the virtual environment includes a 3D virtual (or haptic)object comprising multiple polygonal surface objects. As shown in FIG.44, each surface object is preferably triangular and represented bythree nodes (or vertices) v0, v1, and v2 and a normal vector n. Thevirtual object can be re-shaped to compensate for a physical diameter ofthe tool 50, for example, by offsetting the walls of the virtual objectby a radius of the tool 50. To improve computational performance, whichis important in real-time applications, the polygonal surface objectscan be re-meshed, for example, to eliminate polygons smaller than adesired spatial resolution. When the virtual object is a closed cavity,creation of the virtual object using a CAD system may be simplified bygenerating the virtual object with two surfaces: an outer object surfaceand an inner cavity surface. Using only the inner cavity surface,however, may advantageously reduce the required volume for rendering andthe number of polygonal objects (e.g., triangles, polygons, etc.). Inone embodiment, the rendering process can support uni-directionalentrance behavior to a closed virtual object, where the HIP is permittedto pass through the virtual object only if it is moving from outside toinside.

In step S704 of FIG. 43, the haptic rendering process creates a voxelmap of the polygonal surface objects in the virtual environment. Tocreate the voxel map, the virtual objects in the virtual environment arespatially partitioned into smaller cells (voxels) to reduce the numberof polygonal surface objects and avoid unnecessary collision detectionchecks. As shown in FIG. 45, the virtual objects are segmented into ann_(j)×n_(k) grid. The grid may be regularly spaced or may vary inresolution. Each voxel has a pointer to the polygons that occupy orintersect the voxel. Given a set of polygons, a voxel lookup table isconstructed by the following steps: retrieve the polygon data (i.e., thexyz components for the vertices v0, v1, and v2) for a polygon ofinterest; create a bounding box around the polygon; add a uniqueidentity number for the polygon to the voxels that are within thebounding box; and increase the total number of polygons occupying thevoxel. These steps are repeated until the last polygon is processed. Asshown in FIG. 44 (poly reference frame) and FIG. 45 (voxel referenceframe), a point p in the poly frame is converted into the voxel frameusing the formula v_(ijk)=(int)floor(p/s), where s is voxel size.Examples of voxel and polygon lookup tables are presented in FIGS. 46Aand 46B, respectively.

In step S706 of FIG. 43, the haptic rendering process creates a guideline to a target point or a target region. The guide line functions as apathway or guide wire that guides the HIP to a particular location. Aguide line is useful, for example, to guide the user's movement of thephysical tool 50 so that the tool 50 avoids critical anatomy. A guideline is also useful with a closed haptic volume that the user is unableto traverse. Implementation of a guide line is explained with referenceto FIG. 47, which illustrates a virtual sphere 720. The sphere 720includes an active zone defined by a center and a radius of the sphere720. When the HIP is outside the active zone, the user can freely movethe haptic device 30. When the HIP enters the active zone, the hapticdevice 30 is placed in an approach mode in which a guiding line segment722 is created. The guiding line segment 722 extends, for example, froman entering point 723 on a surface of the sphere 720 to a target point721 (e.g., a target point pair {pe, pt}). Normally, the center of thesphere 720 will be coincident with the target point (or will be within atarget region). When the guiding line segment 722 is activated, the HIPcan move freely along the guiding line segment 723. Motion of the HIPthat deviates from the guiding line segment 722 (e.g., motionperpendicular to the guiding line segment 722), results in a resistingforce that is fed back to the user. As the HIP approaches the targetpoint, a distance from a current location of the HIP to the target pointis monitored. When the distance is smaller than a confine radius, thebehavior of the HIP is restricted, for example, by implementing auni-directionally constrained virtual confining sphere 724. A radius ofthe confining sphere 724 is reduced as the HIP moves closer to thetarget point. When the distance from the HIP to the target point issmaller than a switch radius (represented in FIG. 47 by a switch sphere725), haptic rendering of the virtual object begins.

In step S708 of FIG. 43, the haptic rendering process maps the physicalHIP (e.g., the tip of the tool 50) to virtual space. For example, theforward kinematics process (block 2504) of FIG. 40 computes a Cartesianposition of the physical HIP with respect to an inertial reference frameRi. The coordinate transformation process (block 2506) of FIG. 40performs coordinate transformations between the inertial reference frameRi, a poly frame Rp (a reference frame attached to a polygonal virtualobject), and a voxel frame Rv (a reference frame attached to a voxelarray) as illustrated in FIG. 48. Once the haptic rendering process hasdetermined the position of the HIP with respect to the poly frame Rp,the haptic rendering process proceeds to step S710 and searchescandidate polygonal objects by looking at occupied voxels andneighboring voxels. In step S712, the haptic rendering process checksfor a collision (e.g., the HIP has passed through a polygonal objectsince the last rendering cycle) and determines a virtual proxy pointlocation (e.g., a constrained location of the HIP along a surface of thevirtual object) based on desired virtual proxy behaviors (as describedbelow in connection with FIG. 49). In step S714, desired stiffness anddamping matrices that are predefined in tool coordinates are transformedinto inertial reference frame coordinates. In step S716, a haptic forceto be fed back to the user through the haptic device 30 is computedbased on a desired hardness of a virtual surface defined by the virtualspring and damping force that couples the HIP to the haptic device 30.In step S718, the computed haptic force is displayed or reflected to theuser through the haptic device 30.

As shown in FIGS. 49A and 49B, a location of an initial virtual proxypoint may be determined based on a location HIP(t) of the HIP at acurrent time t and a location HIP(t−1) of the HIP at a previous timet−1. For example, when the HIP is outside a virtual object, the hapticrendering process checks for an initial contact between the HIP and asurface of the virtual object by detecting an intersection between thepolygonal surface objects that comprise the virtual object and a linesegment L extending between the locations HIP(t) and HIP(t−1). Alocation VP(t) of the initial virtual proxy point is computed as theintersecting point of the line segment L and the polygonal surfaceobjects.

FIG. 50 shows a flowchart detailing an embodiment of a haptic renderingalgorithm (block 2508 of FIG. 40) based on polygonal surface objectsaccording to the present invention. In step S100, the position of HIP(t)is updated and transformed to the poly reference frame. In step S101,the algorithm determines whether collisionDetectedFlag(t−1) has a valueof 1. If not, in step S103, the algorithm maps the HIP(t) into voxelcoordinates. In step S105, the algorithm determines whether the HIP(t)is inside a voxel bounding box. If not, no collision is detected, andthe algorithm proceeds to step S115 where the haptic force is set tozero, step S117 where collisionDetectedFlag(t) is set to zero, and stepS119 where the time advances to t=t+1. If step S105 determines that theHIP(t) is inside a voxel bounding box, the algorithm proceeds to stepS107 and searches candidate polygons along a line segment of HIP(t) froma voxel lookup table. In step S109, the algorithm retrieves polygonalinformation from a polygon lookup table. In step S111, the algorithmtests an intersection of the line segment of HIP(t) with the polygonsand, in step S113, determines whether an initial collision is detected.If no collision is detected, the algorithm proceeds to steps S115, S117,and S119 as described above. If a collision is detected, the algorithmproceeds to step S132 (described below).

In contrast, in step S101, if collisionDetectedFlag(t−1) has a value of1, the algorithm follows the right branch of the flowchart. In stepS102, the algorithm maps HIP(t) into voxel coordinates. In step S104,the algorithm searches neighboring polygons at the HIP(t) from a voxellookup table. In step S106, the algorithm retrieves polygonalinformation from a polygon lookup table. In step S108, each neighboringpolygon is tested to determine whether it is intersected by the linesegment from HIP(t−1) to HIP(t). In step S110, the algorithm uses thisinformation to determine whether the HIP(t) has exited the polygons. Ifso, the HIP is no longer penetrating the haptic object, and thealgorithm proceeds to steps S115, S117, and S119 as described above. Ifstep S110 determines that the HIP has not exited the polygons, thealgorithm proceeds to step S112 where the algorithm projects the HIP(t)on each neighboring polygon along the corresponding surface normalvectors of the polygons. If the projected HIP(t) is within a polygon,the algorithm sets the polygon as an On-Polygon and stores theintersecting point. Otherwise, the algorithm finds a point on a boundaryof the polygon that is closest to the projected HIP(t) (all within theplane of the polygon) and stores the point. This process is repeated foreach neighboring polygon. The algorithm then has decision points basedon whether an Active Polygon from the previous time cycle, AP(t−1), wasset to be an On-Polygon in step 22 and whether only a single polygon wasset to be an On-Polygon in the current cycle. Each case is handled asdescribed below.

In step S114, the algorithm determines whether a previous active polygon(on which the virtual proxy point was in contact) is still anOn-Polygon. If so, in step S124 (ActivePolygonPriority), this polygonalsurface has priority to be the active polygon, even if other polygonsare identified as On-Polygons. AP(t) is therefore maintained, and VP(t)is set at the closest point on the active polygonal surface. Forexample, FIG. 51A shows a convex portion of a virtual object defined bytwo adjoining surfaces 540 and 542. When the HIP at t−1 was at alocation 544, the surface 540 is On-Polygon and 542 is not On-Polygon.The virtual proxy point location at t−1 lies at a location 548. If theHIP moves to a location 546, both of the surfaces 540 and 542 areOn-Polygons and locations 550 and 552 are candidates for proxy pointlocation. In this situation, the surface 540 will be selected as anactive polygon and the proxy point location will be updated at thelocation 550. Granting the previous active polygon priority in this wayprevents the choice of the location 552 for the proxy point, which wouldresult in an unnatural jump in the proxy point position and theresulting haptic interaction forces experienced by the user.

If step S114 determines that the previous active polygon is not anOn-Polygon, the algorithm proceeds to step S116 to determine whether asingle On-Polygon is detected. If a single On-Polygon is not detected instep S116, the algorithm checks again in step S120. If a singleOn-Polygon is detected in step S116, the algorithm proceeds to step S118and augments the On-Polygons for a concave corner before checking againfor a single On-Polygon in step S120. If a single On-Polygon is detectedin step S120, the algorithm proceeds to step S126 (described below). Ifa single On-Polygon is not detected in step S120, the algorithm proceedsto step S122 and determines whether multiple On-Polygons are detected.If so, the algorithm proceeds to step S128 (described below). Otherwise,the algorithm proceeds to step S130 (described below).

In step S126 (OnPolygonPriority), AP(t) is updated with a new On-Polygonand VP(t) is set at the closest point on the active polygonal surface.For example, as shown in FIG. 51B, a virtual object has two adjoiningsurfaces 554 and 556. At a time t−1, the HIP is at a location 558 andthe proxy point is at a location 562. When the HIP crosses over asurface border line 564 as the HIP moves from the location 558 to alocation 560, a surface 556 becomes On-Polygon and a location 566becomes the new proxy point location. Thus, if a new single On-Polygonis detected, then the new single On-Polygon becomes the active polygon.

In step S128 (ContinuousSurfacePriority), AP(t) is selected based onforce vector deviation criteria and VP(t) is set at the closest point onthe active polygonal surface. The algorithm detects the multiple newOn-Polygons as illustrated in FIG. 51C, which shows a convex portion ofa virtual object defined by three surfaces, 568, 570, and 572. As theHIP moves from a location 574 to a location 578, the algorithm detectstwo new On-Polygon surfaces, 570 and 572. Thus, locations 580 and 582are candidates for a new virtual proxy point location. In thissituation, the algorithm computes possible candidates of force vector,excluding a damping component, and compares a force vector deviationfrom a previous force vector deviation. The algorithm determines theactive polygon so as to minimize the following objective function:

$J_{continuousSurfcae} = {\min\limits_{i}{{f_{{si},t} \cdot f_{t - 1}}}}$

where f_(si,t) represents a spring force vector defined by a currentlocation of the HIP and a possible location of the virtual proxy pointon the ith polygon and f_(t−1) represents a haptic force displayed atprevious time. In one embodiment, the surface 570 will be the new activepolygon and a location 580 will be the new proxy point position.

In step S130 (MinimumForcePriority), AP(t) is based on minimum forcecriteria and VP(t) is set at the closest point on the active polygonalsurface. As shown in FIG. 51D, the HIP lies at position where noOn-Polygon can be detected. FIG. 51D, illustrates a concave portion of avirtual object defined by three surfaces, 584, 586, and 588. When theHIP moves from a location 590 to a location 594, no surface isOn-Polygon. A location 596 is the closest point to the surfaces 586 and584, a location 598 is the closest point to the surface 588. In thissituation, the algorithm computes distances between the current HIP andpossible proxy point locations and determines a virtual proxy locationto minimize the following objective function:

$J_{minimumSpringForce} = {\min\limits_{i}{{x_{hip} - x_{i,{vp}}}}}$

where x_(i,vp) represents a position of the possible virtual proxy pointon the ith polygon and x_(hip) represents a position of the currenthaptic interface point. In this situation, the algorithm sets either thesurface 584 or the surface 586 as the On-Polygon depending on theirprocessing sequence and the location 596 will be the proxy pointlocation.

In step S132 (ContactPolygonPriority), AP(t) is updated with anintersected polygon and VP(t) is set at the closest point on the activepolygonal surface. The algorithm augments the On-Polygon objects when ahaptic interface point lies in a concave corner where the algorithmdetects one On-Polygonal object and multiple concave surfaces. In thissituation, the application sets the concave polygonal surface toOn-Polygon so that continuous haptic rendering can happen at the concavecorner. FIGS. 52A and 52B show a portion of a concave corner representedby three surfaces, 500, 502, and 504. As the haptic interface pointmoves from a location 506 (with a proxy point location 508) to alocation 510, the surface 504 becomes the only On-Polygonal object. Inorder to avoid the situation in which the algorithm sets the surface 504as an active polygonal surface due to On-Polygon priority behavior andselects a location 514 as the proxy point location, the algorithmaugments the two concave surfaces 500 and 502 into On-Polygon objects.As a result, a location 512 will be a proxy point location according tocontinuous surface priority behavior.

In step S134, stiffness and damping matrices defined in tool coordinatesas constant parameters are transformed into an inertial coordinateframe. When the physical haptic device 30 has different transmissiondevices, such as a cable driven transmission and a direct-driventransmission, isotropic spatial stiffness and damping gains can causeinstability because the physical system has different dynamic propertiesin different directions. For this reason, the spatial stiffness anddamping matrices can be defined with respect to the tool coordinates andneed to be transformed into the inertial coordinate frame. The algorithmcomputes an adjoint transformation matrix based on current rotationaland translational matrices and transforms the spatial stiffness anddamping matrices. Let ^(T)K_(S) and ^(I)K_(S) denote the stiffnessmatrices measured in tool frame and inertial frame, respectively. LetAd_(g) denote the adjoint transformation matrix given as

${Ad}_{g} = \begin{bmatrix}R & {\hat{p}\; R} \\0 & R\end{bmatrix}$

Given a vector p=(px, py, pz)^(T), {circumflex over (p)} denotes askew-symmetric matrix used for representing a cross product as amatrix-vector product:

$\hat{p} = \begin{pmatrix}0 & {- p_{x}} & p_{y} \\p_{x} & 0 & {- p_{z}} \\{- p_{y}} & p_{z} & 0\end{pmatrix}$

where R is the rotational matrix and p is the translational vector.

The algorithm computes the stiffness matrix in the inertial frame:

^(I) K _(S) =Ad _(g) ^(T T) K _(S) Ad _(g)

In step S136, the algorithm computes a spring haptic force vector basedon the location of the haptic interface point and the virtual proxypoint location according to Hooke's law:

F _(spring)(t)=^(I) K _(S)(x _(vp) −x _(hip))

where x_(vp) represents a position of a current virtual proxy point, andx_(hip) represents a position of a current haptic interface point.

In step S138, the algorithm computes a damping haptic force vector basedon the relative motion between the haptic interface point and thevirtual proxy point:

F _(damping)(t)=^(I) K _(D)({dot over (x)}_(vp) −{dot over (x)} _(hip))

where {dot over (x)}_(vp) represents motion of the virtual proxy point,{dot over (x)}_(hip) represents motion of the haptic interface point,and ^(I)K_(D) represents the spatial damping matrix in an inertialframe.

In step S140, the sum of the damping force and spring force is sent tothe physical haptic device 30 as a desired force output (step S718 ofFIG. 43). Prior to controlling the actuators (block 2512 of FIG. 40) ofthe haptic device 30 to output force feedback, the force mapping process(block 2510 of FIG. 40) converts the desired force, F_(desired), tojoint torque, τ:

τ=J ^(T) F _(desired)

where J^(T) is a Jacobian transpose. The computing system 20 thencontrols the actuators of the haptic device 30 to output the jointtorque, τ.

In step S142, collisionDetectedFlag(t)=1. In step S144, the timeadvances tot=t+1. In cases where there may be a transmission withcompliance, backlash, hysteresis, or nonlinearities between the hapticdevice drive (e.g., motors) and position outputs (e.g., joints), it isbeneficial to include position sensors on both the drive end and loadend of the transmission. The load end sensors are used to compute alljoint and endpoint positions because they will most accurately reflectthe actual values. The drive end sensors are used to compute velocitiesin any damping computations, such as for F_(damping) above, which helpsavoid exciting the transmission dynamics.

According to one embodiment, the desired force feedback (or outputwrench) of the haptic device 30 is determined based on a proximity of aportion of the haptic device 30 (e.g., the tool 50) to a virtual (orhaptic) boundary associated with the representation of the anatomy.Thus, if the tool 50 is disposed a sufficient distance from the hapticboundary, a controller commands no haptic forces, and the user is freeto move the tool 50 as if exploring empty space. However, as the tool 50approaches or contacts the haptic boundary, the controller commandstorques to the motors so as to exert the appropriate wrench on theuser's hand via the interface 37. Preferably, a magnitude of the forcefeedback increases as the tool 50 approaches the virtual boundary anddoes not present a discontinuous step that may induce oscillation orunwanted vibration. For example, as the tool 50 approaches the hapticboundary, the haptic device 30 may exert a force in a direction oppositea direction of movement of the user interface 37 such that the userperceives a repulsive or counteracting force that slows and/or stopsmovement of the tool 50. In one embodiment, a rate of increase of theforce as the tool 50 continues moving toward the haptic boundary may be,for example, in a range of 5 N/mm to 50 N/mm. In another embodiment, therate of increase of the force may be approximately 20 N/mm. In thismanner, the user is constrained to not penetrate the haptic boundary toodeeply. When the tool 50 contacts the haptic boundary, the force may besuch that the user feels as if the tool 50 has collided with a physicalobject, such as a wall. The magnitude of the force may prevent the userfrom penetrating the haptic boundary (e.g., a magnitude of approximately100 N or greater) but is preferably set so that the user may breach thehaptic boundary if desired (e.g., a magnitude in a range ofapproximately 20 N to approximately 60 N). Thus, the computing system 20may be programmed to permit the user to overcome the force feedback andmove the haptic device 30 to a desired location. In this manner, thehaptic device 30 constrains the user against inadvertently violating thehaptic boundary, but the user has the option to overpower the hapticdevice 30 and thus retains full control over the surgical procedure.

In one embodiment, the surgical system 10 includes a haptic tuningfeature for customizing a force feedback function of the haptic objectfor a particular user. Such a feature is advantageous because each userhas a unique surgical technique. Thus, different users may use differingamounts of force when maneuvering the tool 50. For example, users whomaneuver the tool 50 with a light touch may sense haptic feedbackearlier than users with a heavier touch. Rather than requiring the userwith the heavier touch to alter his surgical technique to sufficientlysense the haptic feedback, the haptic tuning feature enables the forcefeedback function to be adjusted to accommodate each particular user. Byadjusting (or tuning) the force feedback function, the user canmanipulate the tool 50 with his preferred degree of force and stillsufficiently perceive the haptic feedback exerted by the haptic device30. As a result, the user's ability to maintain the tool within thehaptic boundary is improved. For example, as shown in FIG. 11A, a forcefeedback curve includes a function F(d) that relates force F to distanced. The function F(d), for example, may result from or be a product ofthe haptic object, a coupling stiffness, or a stiffness function. In oneembodiment, F_(i) is a typical haptic interaction force for a user (or agroup of users), and d_(i) is a penetration depth or distance (e.g.,penetration of the tool 50 into the haptic object) where F_(i)=F(d_(i))is true. As shown in FIG. 11B, shifting or offsetting the function F(d)to the left by, for example, d_(i), results in a force feedback functionF(d+d_(i)) that causes the force F to be applied earlier (i.e.,beginning at a penetration distance of −d_(i) rather than at apenetration distance of zero) in a tool's approach to a haptic boundary.Similarly, shifting or offsetting the function F(d) to the right causesthe force F to be applied later in the tool's approach to the hapticboundary. Thus, for a user with a surgical technique that is forceful,it is advantageous to offset the function F(d) to the left to preventthe user from inadvertently pushing too far into the haptic boundary.Thus, haptic tuning may be accomplished by offsetting a force feedbackcurve for controlling the haptic device 30 by a desired value. Haptictuning can also be accomplished by altering a size of a haptic object.For example, a size of a repulsive haptic object 120 a (shown in FIG.11C) can be increased resulting in a haptic object 120 b (shown in FIG.11D). Similarly, a size of a representation of a surgical tool coupledto the haptic device 30 may be altered. For example, a size of a radiusof a tip of a virtual tool 124 a (shown in FIG. 11E) that interacts witha haptic object 122 can be increased resulting in a virtual tool 124 b(shown in FIG. 11F). For a haptic object that acts as a container,tuning can be accomplished, for example, by reducing a size of thehaptic object.

To enable each user to tune the force feedback function, the computingsystem 20 preferably includes programming to enable a graphicalselection interface that can be displayed on the display device 23. Forexample, as shown in FIGS. 11G and 11H, respectively, the graphicalselection interface may be a graphical interface 217 a that enables theuser to set a tuning value, for example, between 0.0 and 1.0 and/or agraphical interface 217 b that enables the user to select, for example,tuning for a “Light,” “Medium,” or “Heavy” touch. The computing system20 may also be programmed to store a desired value of a tuning settingand to associate the desired value with a particular user (e.g., using auser ID tied to a user preference data file) so that the user does nothave to select the tuning setting prior to each use of the surgicalsystem 10.

The haptic device 30 is preferably configured to operate in variousoperating modes. For example, the haptic device 30 may be programmed tooperate in an input mode, a hold mode, a safety mode, a free mode, anapproach mode, a haptic (or burring) mode, and/or any other suitablemode. The operating mode may be selected manually by the user (e.g.,using a selection button represented graphically on the display device23 or a mode switch located on the haptic device 30 and/or the computingsystem 20) and/or automatically by a controller or software process. Inthe input mode, the haptic device 30 is enabled for use as an inputdevice to input information to the surgical system 10. When the hapticdevice 30 is in the input mode, the user may operate the haptic device30 as a joystick or other input device, for example, as described abovein connection with the end effector 35 and/or in U.S. patent applicationSer. No. 10/384,078 (Pub. No. US 2004/0034282), which is herebyincorporated by reference herein in its entirety. Other methods ofinputting information to the surgical system 10 include, for example,moving the wrist 36, moving a joint of the arm 33, and/or moving the arm33 (or a portion thereof). For example, moving the arm 33 toward anobject (e.g., a tracked object) may comprise a first input. Similarly,moving the arm 33 toward the object and twisting the wrist 36 maycomprise a second input. Thus, the surgical system 10 may identify ordistinguish user input based on, for example, a pose of the hapticdevice 30 with respect to a tracked object, movement of a portion of thehaptic device 30 (e.g., the wrist 36), or a combination of pose andmovement. In the hold mode, the arm 33 of the haptic device 30 may belocked in a particular pose. For example, the arm 33 may be locked usingbrakes, control servoing techniques, and/or any other appropriatehardware and/or software for stabilizing the arm 33. The user may desireto place the haptic device 30 in the hold mode, for example, during anactivity such as bone cutting to rest, confer with a colleague, allowcleaning and irrigation of the surgical site, and the like. In thesafety mode, the tool 50 coupled to the haptic device 30 may bedisabled, for example, by shutting off power to the tool 50. In oneembodiment, the safety mode and the hold mode may be executedsimultaneously so that the tool 50 is disabled when the arm 33 of thehaptic device 30 is locked in position.

In the free mode, the end effector 35 of the haptic device 30 is freelymoveable within the workspace of the haptic device 30. Power to the tool50 is preferably deactivated, and the haptic device 30 may be adapted tofeel weightless to the user. A weightless feeling may be achieved, forexample, by computing gravitational loads acting on the segments 33 a,33 b, and 33 c of the arm 33 and controlling motors of the haptic device30 to counteract the gravitational loads. As a result, the user does nothave to support the weight of the arm. The haptic device 30 may be inthe free mode, for example, until the user is ready to direct the tool50 to a surgical site on the patient's anatomy.

In the approach mode, the haptic device 30 is configured to guide thetool 50 to a target object, such as, for example, a surgical site,feature of interest on the patient's anatomy, and/or haptic objectregistered to the patient, while avoiding critical structures andanatomy. For example, in one embodiment, the approach mode enablesinteractive haptic positioning of the tool 50 as described in U.S.patent application Ser. No. 10/384,194 (Pub. No. US 2004/0034283), whichis hereby incorporated by reference herein in its entirety. In anotherembodiment, the haptic rendering application may include a haptic objectdefining an approach volume (or boundary) that constrains the tool 50 tomove toward the target object while avoiding sensitive features such asblood vessels, tendons, nerves, soft tissues, bone, existing implants,and the like. For example, as shown in FIG. 1, the approach volume mayinclude the haptic object 300, which is substantially cone-shaped,funneling from a large diameter to a small diameter in a directiontoward the target object (e.g., a proximal end of the tibia T or adistal end of the femur F). In operation, the user may freely move thetool 50 within the boundaries of the approach volume. As the user movesthe tool 50 through the approach volume, however, the tapering funnelshape constrains tool movement so that the tool 50 does not penetratethe boundaries of the approach volume. In this manner, the tool 50 isguided directly to the surgical site. In another embodiment, shown inFIG. 9, the haptic rendering application creates a virtual object thatrepresents a pathway from a first position to a second position. Forexample, the virtual object may include the haptic object 310, which isa virtual guide wire (e.g., a line) defining a pathway from a firstposition (e.g., a position of the tool 50 in physical space) to a secondposition that includes a target region of the anatomy (e.g., a targetobject such as the haptic object 206). In the approach mode, the virtualobject is activated so that movement of a portion of the haptic device30 (e.g., the tool 50) is constrained along the pathway defined by thehaptic object 310. The surgical system 10 deactivates the virtual objectwhen the tool 50 reaches the second position and activates the targetobject (e.g., the haptic object 206). The tool 50 may be automaticallyplaced in the haptic (or burring) mode when the haptic object 206 isactivated. In a preferred embodiment, the virtual object may bedeactivated to enable the tool 50 to deviate from the pathway. Thus, theuser can override the haptic guidance associated with the haptic object310 to deviate from the guide wire path and maneuver the tool 50 arounduntracked objects (e.g., retractors, lamps, etc.) the cannot beaccounted for when the virtual guide wire is created. Thus, the approachmode enables the user to quickly deliver the tool 50 to a target objectwhile avoiding critical structures and anatomy. In the approach mode,power to the tool 50 is preferably deactivated so that the tool is notaccidentally energized, for example, when the user is inserting the toolthrough an incision or navigating soft tissue in a joint. The approachmode generally precedes the haptic mode.

In the haptic (or burring) mode, the haptic device 30 is configured toprovide haptic guidance to the user during a surgical activity such asbone preparation. In one embodiment, as shown in FIG. 9, the hapticrendering application may include the haptic object 206 defining acutting volume on the tibia T. The haptic object 206 may have a shapethat substantially corresponds to a shape of a surface 74 a of thetibial component 74 (shown in FIG. 10B). Alternatively, the hapticobject 206 may have a shape that is slightly larger than the shape ofthe surface 74 a of the tibial component 74. One advantage of making thehaptic object 206 larger than the implant is that the cutting volumedefined by the haptic object 206 is then large enough to accommodateboth the implant and a cement mantle that is disposed between theimplant and the bone to secure the implant to the bone. A haptic objecthaving a size that deviates from the size of the implant also enablesimplementation of the haptic tuning feature described above inconnection with FIGS. 11A to 11F. The haptic device 30 may enter thehaptic mode automatically, for example, when the tip of the tool 50approaches a predefined point related to a feature of interest. In thehaptic mode, the haptic object 206 may also be dynamically modified(e.g., by enabling and disabling portions of a haptic surface) toimprove performance of the haptic device 30 when sculpting complexshapes or shapes with high curvature as described, for example, in U.S.patent application Ser. No. 10/384,194 (Pub. No. US 2004/0034283), whichis hereby incorporated by reference herein in its entirety. In thehaptic mode, power to the tool 50 is activated, and the tip of the tool50 is constrained to stay within the cutting volume to enable a precisebone resection.

The haptic device 30 may utilize any suitable haptic control scheme,such as, for example, admittance control, impedance control, or hybridcontrol. In an admittance control mode, the haptic device 30 acceptsforce input and yields position (or motion) output. For example, thehaptic device 30 measures or senses a wrench at a particular location onthe haptic device 30 (e.g., the user interface 37) and acts to modify aposition of the haptic device 30. In an impedance control mode, thehaptic device 30 accepts position (or motion) input and yields wrenchoutput. For example, the haptic device 30 measures, senses, and/orcalculates a position (i.e., position, orientation, velocity, and/oracceleration) of the tool 50 and applies an appropriate correspondingwrench. In a hybrid control mode, the haptic device 30 utilizes bothadmittance and impedance control. For example, a workspace of the hapticdevice 30 may be divided into a first subspace in which admittancecontrol is used and a second subspace in which impedance control isused. In a preferred embodiment, the haptic device 30 operates in theimpedance control mode.

During a surgical procedure, the computing system 20 guides the userthrough the procedure. For example, the computing system 20 may beprogrammed to generate a display configured to guide the usermanipulating the haptic device 30 through the procedure. The display maycomprise screens shown on the display device 23 that include, forexample, predefined pages and/or images corresponding to specific stepsof the procedure. The display may also prompt the user to perform one ormore tasks. For example, the display may instruct a user to selectanatomical landmarks on a representation of the anatomy (discussed belowin connection with steps S3 and S4 of FIG. 13). In one embodiment, asshown in FIG. 12, the screen may include a navigation pane 600 fordisplaying images related to a current step of the procedure; a trackedobject pane 602 for showing tracked objects in relation to one another;an information pane 604 for displaying information related to thecurrent step of the procedure, such as, for example, measurement data,error data, status information, selection buttons, and the like; and apane 606 for advancing to subsequent steps in the procedure and/orreturning to previous steps.

Displays or screens associated with the surgical procedure may beconfigured to communicate visual information to the user regarding theprocedure. For example, as shown in FIG. 12, the navigation pane 600 maycreate and display a representation of the anatomy (such as an image orrepresentation of a bone) and a representation 616 of the surgical tool50. For a bone preparation process, the surgical system 10 mayfacilitate the step of preparing the bone to receive an implant bycreating a representation 612 of a portion of material to be removedfrom the bone, superimposing the representation 612 of the portion ofmaterial to be removed on the representation of the bone, and updatingthe representation 612 of the portion of material to be removed with arepresentation 614 of a portion of material actually removed by the tool50 as the user manipulates the haptic device 30. To further aid theuser, the surgical system 10 can update the representation of the boneand the representation 616 of the tool 50 as the bone and the tool 50move. In one embodiment, the representation 612 of the portion ofmaterial to be removed corresponds to a portion of a virtual objectassociated with (or registered to) the bone. Thus, the virtual objectrepresents the portion of material to be removed from the anatomy. Forexample, the virtual object may have a shape substantially correspondingto a shape of a surface of an implant to be fitted to the anatomy (e.g.,in a cementless implant application). For cemented implant applications,the virtual object may have a shape that is larger than a shape of theimplant to allow room for a cement mantle between the implant and thebone. The above-described bone preparation steps may be performed, forexample, on a first bone (e.g., the tibia T) and then repeated for asecond bone (e.g., the femur F).

In one embodiment, the portion of bone to be removed may be indicatedfor example, using a color that is different from a color of surroundingbone. For example, the portion of bone to be removed may be coloredgreen while the surrounding bone is colored white. As the user removesbone with the tool 50, the computing system 20 updates the image in thenavigation pane 600 so that when the tool 50 reaches a desired cuttingdepth, the color changes from green to white. Similarly, if the tool 50cuts beyond the desired cutting depth, the color changes from white tored. Thus, the surgical system 10 creates a representation of a portionof material to be removed in a first color and, when a desired amount ofmaterial has been removed, creates a representation of the materialremoved by the haptic device 30 in a second color. If the materialremoved by the haptic device exceeds the desired amount of material, thesurgical system 10 creates a representation of the material removed in athird color. In a preferred embodiment, a haptic object includes anarray of volume elements (i.e., voxels) having a first portioncorresponding to a portion of bone to be removed, a second portioncorresponding to surrounding bone, and a third portion corresponding toa cutting depth that is outside a predefined cutting volume. The voxelsin the first portion may be a first color (e.g., green), the voxels inthe second portion may be a second color (e.g., white), and the voxelsin the third portion may be a third color (e.g., red). As the tool 50overlaps a voxel, the voxel is cleared thereby exposing an adjacentunderlying voxel. Thus, if the user cuts too deeply with the tool 50,green and/or white voxels may be cleared to expose underlying redvoxels. In another embodiment, the surgical system 10 may provide avisual indication of a distance between the tip of the tool 50 and asurface of a haptic object in registration with the patient asdescribed, for example, in U.S. patent application Ser. No. 10/621,119(Pub. No. 2004/0106916), which is hereby incorporated by referenceherein in its entirety. The navigation pane 600 may also include, forexample, a representation of a current position of the tool 50, adesired trajectory of the tool 50, a representation of an implant,and/the like.

In addition to communicating with the user visually, the computingsystem 20 may be programmed to emit audible signals (e.g., via theacoustic device). For example, in one embodiment, the computing system20 may emit sounds (e.g., beeps) indicating that a cutting depth of thetool 50 is too shallow, approximately correct, or too deep. In anotherembodiment, the surgical system 10 may provide an audible indication ofa distance between the tip of the tool 50 and a surface of a hapticobject in registration with the patient as described, for example, inU.S. patent application Ser. No. 10/621,119 (Pub. No. US 2004/0106916),which is hereby incorporated by reference herein in its entirety. Thecomputing system 20 may also be programmed to control the haptic device30 to provide tactile feedback to the user, such as, for example, avibration indicating that the tool 50 has reached or exceeded thedesired cutting depth. The software of the computing system 20 may alsoinclude programs or processes that automatically prompt a user toperform certain tasks, such as, for example, segmenting an image of adiagnostic image data set, selecting points on the patient's anatomy todefine a mechanical axis, touching (or “painting”) points on a surfaceof the bone with a registration probe, entering data (e.g., implantsize, burr size, etc.), and the like.

FIG. 13 illustrates an embodiment of a process for using the surgicalsystem 10 for surgical planning and navigation of a unicondylar kneereplacement. The process of FIG. 13 is intended as an exemplaryillustration only. In other embodiments, the order of the steps of theprocess may be rearranged in any manner suitable for a particularsurgical application. Additionally, other embodiments may include all,some, or only portions of the steps illustrated in FIG. 13 and maycombine any of the steps of FIG. 13 with existing and/or later developedsurgical approaches. The unicondylar knee replacement procedure detailedin the process of FIG. 13 is for a medial side of the knee. The sameprocess may be used, however, for a lateral side of the knee. Moreover,the illustrated unicondylar procedure is exemplary only. The surgicalsystem 10 may also be used to perform a total knee replacement procedureor other joint replacement procedure involving installation of animplant. The implant may include any implant or prosthetic device, suchas, for example, a total knee implant; a unicondylar knee implant; amodular knee implant; implants for other joints including hip, shoulder,elbow, wrist, ankle, and spine; and/or any other orthopedic and/ormusculoskeletal implant, including implants of conventional materialsand more exotic implants, such as orthobiologics, drug deliveryimplants, and cell delivery implants. In one embodiment, the implant isa modular knee implant as described in U.S. patent application Ser. No.11/312,741, filed Dec. 30, 2005, which is hereby incorporated byreference herein in its entirety.

In the embodiment of FIG. 13, steps S1 to S4 are performedpreoperatively, and steps S5 to S14 are performed intraoperatively. Instep S1, patient information or data may be input to the surgical system10. In step S2, a preoperative diagnostic image (e.g., a CT data file)is loaded into the surgical system 10 and segmented. In step S3, femorallandmarks are selected. In step S4, tibial landmarks are selected. Instep S5, a homing process is performed on the haptic device 30 toinitialize position sensors in the arm 33 of the haptic device 30. Instep S6, calibration of a registration probe is verified. In step S7,the anatomy trackers 43 a and 43 b are attached to the patient. In stepS8, patient anatomy is registered. In step S9, the haptic device 30 iscalibrated. In step S10, an initial placement of a tibial implant (e.g.,a tibial component 74 as shown in FIG. 16B) is planned. A depth of theinitial placement may be guided by points that are selected on a surfaceof the tibial plateau cartilage and transferred to a planning screen onthe display device 23 using the registration computed in step S8. Instep S11, the tibia T is prepared or sculpted. In step S12, a tibialtrial implant is fitted to the prepared surface of the tibia T. In stepS13, an initial placement of a femoral implant (e.g., a femoralcomponent 72 as shown in FIG. 16A) is planned, for example, using pointsrelated to a position of the tibial trial implant at various flexions ofthe leg. In step S14, the femur F is prepared or sculpted. In step S15,a femoral trail implant is fitted to the prepared surface of the femurF. A trial reduction process is performed in which the user assesses thefit of the femoral and tibial trial implants and makes any desiredadjustments (e.g., repeating implant planning and/or bone sculpting)prior to installing the femoral component 72 and the tibial component74.

In step 51, patient information may be input to the surgical system 10.For example, the surgical system 10 may display a screen on the displaydevice 23 requesting information about the patient. Patient informationmay include any relevant patient data, such as, for example, name, birthdate, identification number, sex, height, and weight. Patientinformation may also include information related to the procedure to beperformed, such as, for example, specifying the appropriate leg (e.g.,left or right), specifying the portion of the joint to be replaced(medial, lateral, total), and selecting preoperative diagnostic imagedata files (e.g., CT data files) of the patient's anatomy. Patientinformation may be input to the surgical system 10 in any known manner.For example, the user may directly enter the patient information or thepatient information may be downloaded into the surgical system 10 from ahospital network or electronic storage medium. Preferably, patientinformation is recorded when the patient's anatomy is imaged, is savedin an image data file (e.g., a CT data file), and is loaded into thesurgical system 10 along with the image data file in step S2 below. Thecomputing system 20 may also request information related to the user(e.g., name, identification number, PIN number, etc.), the surgicalfacility, and/or any other information useful for identification,security, or record keeping purposes. As with the patient data, userinformation may also be included in the image data file. As a safeguard,the computing system 20 may include a verification feature that promptsthe surgeon (or other licensed medical professional) to verify patientinformation that has been input to the surgical system 10.

In step S2, a representation of the anatomy is created by loading imagedata files containing preoperative diagnostic images (e.g., an upper legimage, a knee image, and a lower leg image) into the surgical system 10.The diagnostic images constitute a representation of the anatomy.Additional representations of the anatomy may be generated by segmentingthe images. For example, the surgical system 10 may display a screen 81a (shown in FIG. 15) to guide the user through the segmentation processfor the femur F and a screen 81 b (shown in FIG. 16) to guide the userthrough the segmentation process for the tibia T. As shown in FIGS. 15and 16, the preoperative diagnostic images are divided into segments orslices that span the anatomy of interest. The segmentation data is usedby the surgical system 10 to create a representation of the anatomy ofthe patient, including, for example, a representation of a first boneand a representation of a second bone. The first and second bones may bethe femur F and the tibia T (or vice versa). In one embodiment,three-dimensional computer models representative of the anatomy arecreated based on object boundaries (e.g., at bone or cartilage surfaces)generated by the segmentation. The greater the number of segments orslices, the higher the accuracy of the model. In one embodiment, thenumber of slices taken across a portion of the anatomy of interest is 30slices. In another embodiment, the number of slices taken may be in arange of 20 slices to 100 slices. The segmentation process may utilizeany suitable segmentation method, such as for example, texture-basedsegmentation, thresholding-based interactive segmentation, region-basedobject segmentation, and/or polygon-based manual tracing. In oneembodiment, an “edge measure” based interactive segmentation known as“livewire” is used.

In steps S3 and S4, the user designates landmarks on the representationof the first bone and the representation of the second bone. Forexample, in step S3, the user may designate femoral landmarks on animage of the femur F. The femoral landmarks are used by the surgicalsystem 10 to associate (or register) the patient's physical anatomy withthe representation of the anatomy (e.g., diagnostic images, modelsgenerated from segmentation, anatomical models, etc.). As shown in FIGS.17 to 19, the surgical system 10 generates screens 82 a, 82 b, and 82 c,respectively, to guide the user in specifying the femoral landmarks. Forexample, the surgical system 10 may direct the user to specify a hipcenter (FIG. 17), a medial epicondyle (FIG. 18), and a lateralepicondyle (FIG. 19). In one embodiment, the user may select the femorallandmarks on a displayed image using a mouse or touch screen. In anotherembodiment, the computer may be programmed to determine the location ofthe femoral landmarks in the images, for example, using algorithmsdesigned to locate distinguishing features in the diagnostic images.

Similarly, in step S4, the user may designate tibial landmarks on animage of the tibia T. The tibial landmarks are used by the surgicalsystem 10 to associate (or register) the patient's physical anatomy withthe representation of the anatomy (e.g., diagnostic images, modelsgenerated from segmentation, anatomical models, etc.). As shown in FIGS.20 to 23, the surgical system 10 generates screens 83 a, 83 b, 83 c, and83 d, respectively, to guide the user in specifying the tibiallandmarks. For example, the surgical system 10 may direct the user tospecify a medial malleolus (FIG. 20), a lateral malleolus (FIG. 21), arotational landmark (FIG. 22), and a knee center (FIG. 23). As shown inFIG. 22, the rotational landmark may be, for example, intersecting axes183 that the user adjusts to be parallel to the anterior and posteriorportions of the transverse view of the anatomy in the screen 83 c. Therotational landmark enables the surgical system 10 to account for anyrotation of the leg L in the diagnostic image (e.g., if the CT scan wastaken with the leg L leaning to the side rather than in exactanterior-posterior alignment) and to adjust the transverse view so thatthe anterior and posterior portions are aligned (e.g., as shown in aframe 806 of FIG. 35). In one embodiment, the user may select the tibiallandmarks on a displayed image using a mouse or touch screen. In anotherembodiment, the computer may be programmed to determine the tibiallandmarks, for example, using algorithms designed to locatedistinguishing features in the diagnostic images.

In step S5, a homing process initializes the position sensors (e.g.,encoders) of the haptic device 30 to determine an initial pose of thearm 33. Homing may be accomplished, for example, by manipulating the arm33 so that each joint encoder is rotated until an index marker on theencoder is read. The index marker is an absolute reference on theencoder that correlates to a known absolute position of a joint. Thus,once the index marker is read, the control system of the haptic device30 knows that the joint is in an absolute position. As the arm 33continues to move, subsequent positions of the joint can be calculatedbased on the absolute position and subsequent displacement of theencoder. The surgical system 10 may guide the user through the homingprocess by providing instructions regarding the positions in which theuser should place the arm 33. The instructions may include, for example,images displayed on the display device 23 showing the positions intowhich the arm 33 should be moved.

In step S6, an instrument (e.g., a registration probe such as theinstrument 150) is checked to verify that the instrument is calibrated.For example, step S6 may be used to verify that a registration probe hasa proper physical configuration. As discussed above in connection withthe instrument tracker 49, calibration of a probe that includes theinstrument tracker 49 may be accomplished by inserting a tip of theprobe into the divot 47 a of the end effector tracker 47, holding thetip in place, and detecting the instrument tracker 49 and the endeffector tracker 47 with the detection device 41. The detection device41 acquires pose data, and the surgical system 10 compares an actualgeometric relationship between the trackers 49 and 47 to an expectedgeometric relationship between the trackers 49 and 47. Deviation betweenthe actual and expected geometric relationships indicates one or morephysical parameters of the probe is out of calibration. As shown in FIG.24, during the verification process, the surgical system 10 may displaya screen 84 showing a graphical representation of the probe, theinstrument tracker 49, and the end effector tracker 47 on the displaydevice 23.

Prior to step S7, the patient arrives in the operating room. As shown inFIG. 1, the patient (only a leg L is shown) is positioned on anoperating table 102, and the haptic device 30 is positioned relative tothe patient so that the haptic device 30 can attain a variety of posesuseful for the procedure. To achieve an appropriate level of sterility,the haptic device 30 may be sterilized in any suitable manner. Forexample, the end effector 35 and the tool 50 may be sterilized usingconventional sterilization processes, and other portions of the hapticdevice 30 may be sterilized and/or covered with a sterile covering ordrape. In one embodiment, the arm 33 and the base 32 of the hapticdevice 30 are covered with a sterile plastic wrapping, and the platform39 is covered with a sterile drape.

To elevate the leg L of the patient and enable the leg L to be bent atdifferent angles, the leg L may be supported or braced in a leg holder(or support device) that can be moved into various positions. In oneembodiment, the leg holder is a manually adjustable leg holder 62. Asshown in FIG. 14A, the leg holder 62 includes a first portion 62 a and asecond portion 62 b slidably disposed on a base 64 and connected at ahinge 62 c. The base 64 includes a locking mechanism (not shown) forfixing the first and second portions 62 a and 62 b in position. The legL may be secured on the leg holder 62 in any suitable manner, such as,for example, using one or more straps 63. Alternatively or in additionto tracking a pose of the bones of the leg L (e.g., with the anatomytrackers 43 a and 43 b or the mechanical tracking system 240), a pose ofthe leg holder 62 may be tracked (e.g., with position sensors, anon-mechanical tracking system, or a mechanical tracking system asdescribed above). If only the leg holder 62 is tracked, the leg L shouldbe sufficiently secured to the leg holder 62 (e.g., with the straps 63)so as to prevent relative motion between the leg L and the leg holder62. In operation, to move the leg L, the user manipulates the leg L (orthe leg holder 62) so that the first and second portions 62 a and 62 bslide along the base 64 and articulate about the hinge 62 c.Articulation about the hinge 62 c causes an angle a of the leg holder 62to either increase or decrease. The leg holder 62 is preferablyconfigured so that the angle a can be adjusted from approximately 0 ° toapproximately 180°. As a result, the leg L can be moved between a fullyextended position and a fully flexed position. As the leg L moves, anincision 128 (e.g., a minimally invasive incision) made on a side of thepatient's knee shifts along the leg L. Shifting of the incision 128enables the surgeon to use the same incision to insert instruments tosculpt both a proximal end of the tibia T and a distal end of the femurF. As a result, multiple incisions may be avoided, and a size of theincision 128 can be kept small.

In another embodiment, the leg holder 62 may be automated, for example,by the addition of position sensors (e.g., encoders) and a motorcontrolled by the computer 21 and/or the computer 31. The motor mayenable the leg holder 62 to be fully automated or may simply perform apower-assist function to aid the user in positioning the leg holder 62.One advantage of fully automating the leg holder 62 is that an automatedleg holder can be controlled by the surgical system 10 to autonomouslymove the leg L to a correct position, which spares the user thedifficulty of physically maneuvering the leg L and guessing the correctposition for the leg L. For example, a process for controlling anautomatic leg holder (or support device) may include placing a firstbone (e.g., the tibia T) and/or a second bone (e.g., the femur F) in theleg holder 62 and actuating the leg holder 62 to move the first boneand/or the second bone from a first position to a second position. Theprocess may also include the steps of determining an actual pose of thefirst bone and/or the second bone (e.g., from the anatomy trackers 43 aand 43 b), determining a desired pose of the first bone and/or thesecond bone, and actuating the leg holder 62 to move the first boneand/or the second bone from the actual pose to the desired pose. As theleg holder 62 moves, the surgical system 10 can monitor the position ofthe first bone and/or the second bone. When the first bone and/or thesecond bone is in the desired pose, the process stops. In addition totracking the position of the first and second bones, the position of theleg holder 62 may be monitored (e.g., using position sensors on the legholder 62).

In another embodiment, as shown in FIG. 14B, the surgical system 10includes a leg holder 162. During a surgical procedure, the leg holder162 may be mounted on the operating table 102 or other suitablestructure. An upper portion of the leg L of the patient rests in the legholder 162 on a support 164 so that the lower portion of the leg L isfreely suspended. Such an approach is advantageous because gravitationalforces acting on the suspended portion of the leg L pull open the kneejoint to thereby provide greater access to the joint.

In step S7, the surgical system 10 prompts the user to attach theanatomy trackers 43 a and 43 b to the patient. As shown in FIG. 25, thesurgical system 10 may also generate a screen 85 to enable the user tooptimize positioning of tracked objects with respect to the detectiondevice 41. For example, the screen 85 may include a representation 85 aof the detection device 41 and a representation 85 b of a field of viewof the detection device 41. The screen may also display a representationF1 of the anatomy tracker 43 a , a representation T1 of the anatomytracker 43 b, a representation H of the haptic device tracker 45, and/ora representation of any other trackable element in relation to the fieldof view 85 a of the detection device 41. In one embodiment, each of therepresentations F1, T1, and H is displayed in a different color toenable the user to distinguish between each of the tracked objects. Inanother embodiment, the representations F1, T1, and H1 may change to adifferent color when the tracked object is near a boundary of the fieldof view of the detection device 41. In this manner, the user maydetermine whether tracked objects are sufficiently positioned within thefield of view of the detection device 41.

In one embodiment, once the anatomy trackers 43 a and 43 b are attached,a range of motion (ROM) of the knee joint is captured (e.g., by movingthe knee joint through the ROM while tracking the anatomy trackers 43 aand 43 b with the tracking system 40). The captured ROM data may be usedto assess relative placement of the femoral and tibial implants. Forexample, the ROM data augmented by registration of the physical patientto the preoperative image data allows the user to plan relative implantpositions consistent with a current condition of the patient's softtissue (e.g., based on disease state, age, weight, current ROM, etc.).In one embodiment, implant depth can be planned so that the installedimplants fill the pre-existing joint gap (i.e., the gap existingpreoperatively between the tibia T and the femur F) in the knee of thepatient. In addition, other important parameters such as, for example,adequate contact, anterior and posterior coverage, and proper relativerotation of the implant pair can be evaluated throughout the ROM of theknee joint. In this way, comprehensive placement planning for bothimplants can be performed before cutting any bone. The ROM data may alsobe used (e.g., during the implant planning steps S10 and S13) to displayrelative positions of the femoral and tibial implants at extension,flexion, and various angles between extension and flexion on the displaydevice 23.

After the anatomy trackers 43 a and 43 b are fixed to the patient, theprocess proceeds to step S8 in which the patient's physical anatomy isregistered to the representation of the anatomy. For example, the femurF and the tibia T of the patient may be registered in standard fashionusing a paired-point/surface match approach based on the femoral andtibial landmarks specified in steps S3 and S4, respectively. Thesurgical system 10 generates screens to guide the user through theregistration process. For example, a screen 86 a (FIG. 26) instructs theuser to rotate the femur F to find a center of a hip of the leg L. Inone embodiment, the surgical system 10 determines the hip center bydetermining a center of a pivot point of the femur F based on motion ofthe anatomy tracker 43 a during the rotation of the femur F. Screens 86b, 86 c, 86 d, 86 e, and 86 f (shown in FIGS. 27, 28, 29, 30, and 31,respectively) instruct the user to point a registration probe to variousanatomical landmarks (e.g., medial malleolus, lateral malleolus, medialepicondyle, lateral epicondyle, posterior border of anterior cruciateligament (ACL) attachment, etc.) and to select the landmarks. Forexample, the user may place a tip of a tracked registration probe on therelevant landmark and select the landmark with a foot pedal or otherinput device 25. When the user selects the landmark, the detectiondevice 41 acquires data related to the pose of the registration probe,which is then used to calculate the location of the landmark. Based onthe landmark pose data and the landmark designations in the diagnosticimages (in steps S3 and S4), the surgical system 10 registers thephysical anatomy to the diagnostic images by determining acorrespondence between the physical landmarks on the patient and thelandmarks in the diagnostic images. The accuracy of this landmark-basedregistration may be improved by acquiring surface data for the femur Fand the tibia T. For example, the surgical system 10 may generate ascreen 86 g (FIG. 32) instructing the user to touch points on (or“paint”) a surface of a distal end of the femur F with the registrationprobe. As the user paints the surface (e.g., by inserting a tip of theregistration probe through the incision 128), the surgical system 10periodically acquires a position of the probe tip and displays theacquired tip positions on the screen 86 g as dots 900. For bone surfacesthat are overlaid with cartilage, a sharp probe may be used to piercethe cartilage and collect points on the surface of the bone (as opposedto points on the surface of the cartilage). Similarly, the surgicalsystem 10 generates a screen 86 h (FIG. 33) and instructs the user topaint a surface of a proximal end of the tibia T with the registrationprobe. As the user paints the surface (e.g., by inserting the probe tipthrough the incision 128), the surgical system 10 periodically acquiresa position of the probe tip and displays the acquired tip positions onthe screen as the dots 900. As with the femur, a sharp probe may be usedto pierce any cartilage so that points on the surface of the bone (asopposed to the surface of the cartilage) are collected. Additionally, ahooked probe may be used to facilitate the collection of points at aposterior margin of the tibial plateau.

In step S9, the haptic device 30 is calibrated to establish a geometricrelationship between a coordinate frame of reference of the hapticdevice 30 and the haptic device tracker 45. If the haptic device tracker45 is fixed in a permanent position on the haptic device 30, calibrationis not necessary because the geometric relationship between the tracker45 and the haptic device 30 is fixed and known (e.g., from an initialcalibration during manufacture or setup). In contrast, if the tracker 45can move relative to the haptic device 30 (e.g., if the arm 34 on whichthe tracker 45 is mounted is adjustable) calibration is necessary todetermine the geometric relationship between the tracker 45 and thehaptic device 30. The surgical system 10 initiates the calibrationprocess by generating a screen 87 (shown in FIG. 34) instructing theuser to calibrate the haptic device 30. Calibration involves securingthe haptic device tracker 45 in a fixed position on the haptic device 30and temporarily affixing the end effector tracker 47 to the end effector35. The end effector 35 is then moved to various positions in a vicinityof the anatomy (e.g., positions above and below the knee joint,positions medial and lateral to the knee joint) while the trackingsystem 40 acquires pose data for the trackers 47 and 45 relative to thetracking system 40 in each of the positions. In addition, the surgicalsystem 10 determines a pose of the end effector 35 relative to thehaptic device 30 based on data from the position sensors in the arm 33.Using the acquired data, the surgical system 10 is able to calculate thegeometric relationship between the haptic device tracker 45 and acoordinate frame of reference of the haptic device 30. The end effectortracker 47 may then be removed from the haptic device 30. Duringsurgery, the surgical system 10 can determine a pose of the tool 50based on (a) a known geometric relationship between the tool 50 and theend effector 35, (b) a pose of the end effector 35 relative to thehaptic device 30 (e.g., from the position sensors in the arm 33), (c)the geometric relationship between the haptic device 30 and the hapticdevice tracker 45 determined during calibration, and (d) the global orgross position of the haptic device 30 (e.g., from the pose of thehaptic device tracker 45 relative to the tracking system 40). Thecalibration process of step S9 need not be performed if the hapticdevice tracker 45 has not moved with respect to the haptic device 30since the previous calibration and the previously acquired calibrationdata is still reliable.

In step S10, the user plans bone preparation for implanting a firstimplant on a first bone. In a preferred embodiment, the first bone isthe tibia T, the first implant is the tibial component 74, and bonepreparation is planned by selecting a location on a proximal end of thetibia T where the tibial component 74 will be installed. To facilitateimplant planning, the surgical system 10 generates a screen 88 b (shownin FIG. 35) that includes various views of representations of the firstand second bones (i.e., the tibia T and the femur F, respectively). Forexample, the screen 88 b may include a frame 800 showing athree-dimensional rendering, a frame 802 showing a sagittal view, aframe 804 showing a coronal view, and a frame 806 showing a transverseview. Additionally, a frame 807 may display selection buttons and datarelative to implant placement and selection, such as, for example,implant size, depth, internal/external angle, varus/valgus angle,flexion angle, etc. Additionally, a mechanical axis of the femur F(e.g., an axis from the hip center or center of the femoral head to theknee center) and/or a mechanical axis of the tibia T (e.g., an axis fromthe knee center to the ankle center) may be displayed to aid in implantplanning. The user can select and display multiple different slices orthree-dimensional reconstructions of the images and can overlay acontour representing a surface of the tibia T (or the femur F) on theslice images to facilitate implant planning. In one embodiment, thesurgical system 10 proposes an appropriately sized tibial implant andplacement location and associates a representation (or implant model)808 b of the tibial implant with the representation of the tibia T. Tovisually aid the user, the surgical system 10 may also superimpose therepresentation 808 b of the tibial implant on the representation of thetibia T. The user has the option to modify the proposed placement. Forexample, the user may change the size, anterior/posterior position,medial/lateral position, and rotations of the implant model 808 b (e.g.,by dragging or adjusting the implant model 808 b with a mouse). Changesmade to the implant model 808 b in one of the frames causes the implantmodel 808 b in the remaining frames to automatically update. When theuser completes tibial implant planning, the surgical system 10 storesthe chosen location. Implant planning may be repeated and adjusted asdesired at any time during the surgical procedure, such as, for example,prior to, during, and/or after bone preparation.

The location of the tibial component 74 may be selected, for example,based on surgical judgment, to generally center the tibial component 74on the tibial plateau, to position the tibial component 74 on hard boneto avoid subsidence over time, to position the tibial component 74 adesired distance from one or more landmarks, and/or based on a cartilagesurface identified by a tracked tool. In one embodiment, the userselects a location for the tibial component 74 by moving the implantmodel 808 b (shown in FIG. 35) to the general implantation area. Usingthe transverse view in the frame 806, the user adjusts the implant model808 b rotationally so that the flat side of the implant model 808 b isapproximately parallel to the anterior cruciate ligament (ACL) andposterior cruciate ligament (PCL) attachment points. Aninternal/external angle dimension (designated “External”) in the frame807 displays the resulting internal/external angle. Using the coronalview in the frame 804, the user adjusts the varus/valgus angle of theimplant model 808 b. A varus/valgus angle (designated “Varus”) dimensionin the frame 807 displays the resulting varus/valgus angle. Using thesagittal view in the frame 802, the user adjusts the posterior slope ofthe implant model 808 b. A flexion angle dimension (designated“Flexion”) in the frame 807 displays the resulting flexion angle. Theuser may adjust a depth of the implant model 808 b in the tibia T byadjusting a depth bar (designated “Depth”) in the frame 807. The usermay also change the size of the implant model 808 b using a sizeselection box (designated “Size”) in the frame 807. To aid inpositioning of the implant model 808 b, the user may display themechanical axes using a button (designated “Display Axes”) in the frame807. The frame 807 may also include a button (designated “BothImplants”) to enable the user to display the tibial and femoral implantson the screen 88 b simultaneously.

In a preferred embodiment, soft tissue in the joint gap of the knee istaken into account when selecting a placement for the tibial component74. For example, the first implant (i.e., the tibial component 74) maybe planned so that a top surface of the tibial component 74 is alignedwith a top surface of cartilage in the joint gap. Such an approachadvantageously preserves the natural configuration of the joint spacewhich may improve implant performance and longevity. In this embodiment,a height of a cartilage surface above the first bone (i.e., the tibia T)is detected, a representation of the first bone and a representation ofthe height of the cartilage surface are created, and bone preparationfor implanting the first implant on the first bone is based at least inpart on the detected height of the cartilage surface. For example, thetop surface of the cartilage may be detected (or mapped) by placing atip of a tracked probe at a point on the top surface of the cartilageand selecting the point with a button (designated “Map Point) in theframe 807. The representation of the height of the cartilage surface mayinclude a numerical representation (e.g., a distance from the first boneto the cartilage surface) and/or a visual representation (e.g., mappedpoints may be displayed as points 809 in the frame 800). Severalcartilage points may be mapped (e.g., an anterior point, a posteriorpoint, a medial point, etc.). The user aligns at least a portion of therepresentation of the first implant (i.e., the implant model 808 b) withthe representation of the height of the cartilage surface (i.e., thepoints 809), for example, by adjusting the depth of the implant model808 b so that the upper edges of the implant model 808 b align with themapped cartilage points 809. In this embodiment, therefore, the surgicalsystem 10 associates the representation of the first implant with therepresentation of the first bone based at least in part on a detectedlocation of cartilage in a region of the first bone. In this manner, thedepth of the tibial component may be selected based on a thickness ofthe cartilage on the tibial plateau. Thus, the surgical system 10enables the user to determine a placement of the tibial component 74that aligns the top surface of the tibial component 74 with the topsurface of the cartilage prior to any bone cutting.

If desired, in step S10, the user may also preoperatively plan aninitial placement of the second implant (i.e., the femoral component 72)on the second bone (i.e., the femur F). Preferably, however, step 10includes only preoperative planning of the first implant (i.e., thetibial component 74). Femoral planning is delayed until after sculpting(step S11) and trialing (step S12) of the tibia T so that the size,internal/external rotation, and medial/lateral position of the femoralcomponent can be determined based on the position of the tibial trial inrelation to the femur F.

Steps S11 to S15 encompass the bone preparation process. In step S11,the first bone (e.g., the tibia T) is prepared to receive the firstimplant (e.g., the tibial component 74) by manipulating the tool 50 tosculpt the first bone. In step S12, a trial implant is fitted to theprepared feature on the first bone. In step S13, an initial placement ofthe second implant (e.g., the femoral component) is planned (or apreviously planned placement of the second implant may be revisited andadjusted). In step S14, the second bone (e.g., the femur F) is preparedto receive the second implant after preparation of the first bone. Instep S15, a trial implant is fitted to the prepared features on thesecond bone.

Bone preparation (or sculpting) may be accomplished, for example, usinga spherical burr to sculpt or contour the bone so that a shape of thebone substantially conforms to a shape of a mating surface of theimplant. The user has the option to prepare either the femur F or thetibia T first. In a preferred embodiment, the tibia T is prepared first(step S11), and the tibial trail implant is fitted to the preparedsurface of the tibia T (step S12). Placement of the femoral component 72is then planned (step S13) followed by preparation of the femur F (stepS14). Such an approach is advantageous because the user can planplacement of the femoral component 72 based on a physical relationshipbetween the tibial trial implant and the femur F at various flexions ofthe leg. Additionally, prior to sculpting the tibia T and the femur F, aportion (e.g., a 3 mm thick section) of the medial posterior condyle ofthe femur F is preferably removed with a sagittal saw. Removing thisportion of the posterior condyle reduces the likelihood of boneimpingement of the posterior condyle on the tibial component 74 andprovides additional workspace in the knee joint.

Throughout surgical procedure, the surgical system 10 monitors movementof the anatomy to detect movement of the anatomy and makes appropriateadjustments to the programs running on the computer 21 and/or thecomputer 31. In one embodiment, the surgical system 10 adjusts therepresentation of the anatomy in response to the detected movement. Forexample, the surgical system 10 adjusts the representation of the firstbone (i.e., the tibia T) in response to movement of the first bone andadjusts the representation of the second bone (i.e., the femur F) inresponse to movement of the second bone. The surgical system 10 can alsoadjust a virtual object associated with the anatomy in response to thedetected movement of the anatomy. For example, the virtual object mayinclude a virtual boundary that comprises a representation of an implant(e.g., the virtual boundary may correspond to a shape of a surface ofthe implant). When bone preparation is planned, the surgical system 10associates the representation of the implant with the representation ofthe bone on which the implant is to be implanted. During the surgicalprocedure, the surgical system 10 adjusts the virtual boundary inresponse to movement of the bone.

In step S11, the first bone is prepared to receive the first implant bymanipulating the tool 50 to sculpt the first bone. In one embodiment,the tibia T is prepared by forming the medial tibial pocket feature onthe proximal end of the tibia T. Upon installation of the tibialcomponent 74, the medial tibial pocket feature will mate with thesurface 74 a of the tibial component 74 (shown in FIG. 10B). As shown inFIG. 36, the surgical system 10 displays a screen 89 showing a graphicalrepresentation of the tibia T including, for example, an representation612 of a portion 618 of bone to be removed and a graphicalrepresentation of the tool 50 showing a tool tip 616 a and a tool shaft616 b. The screen 89 may optionally display a position of the oppositebone (i.e., the second bone or femur F) to guide the user in avoidingaccidental cutting of a surface of the opposite bone. The portion 618 ofbone to be removed is preferably colored a different color from thesurrounding bone. For example, the portion 618 may be colored greenwhile the surrounding bone is colored white. The haptic device 30 entersthe approach mode in which a haptic object (e.g., the haptic object 300shown in FIG. 1, the haptic object 310 shown in FIG. 9) in the form ofan approach path assists the user in guiding the tip of the tool 50through the incision 128 and toward the feature of interest on thepatient (i.e., the portion of bone on the patient's anatomycorresponding to the portion 618 graphically represented on the screen89). In the approach mode, the tool 50 is disabled to avoid accidentalcutting as the tool 50 traverses the incision 128 and is navigated tothe feature of interest. The surgical system 10 automatically places thehaptic device 30 in the haptic (or burring) mode, for example, when thetip of the tool 50 approaches a predefined point related to the featureof interest. When the haptic device 30 is placed in the haptic mode, thesurgical system 10 also initiates an occlusion detection algorithm.

The occlusion detection algorithm is a safety feature that turns offpower to the tool 50 if either the haptic device tracker 45 or one ofthe anatomy trackers 43 a or 43 b is at any time occluded while thehaptic device 30 is in the haptic (or burring) mode. If an occludedstate is detected, the occlusion detection algorithm may also cause awarning message to be displayed on the display device 23, an audiblealarm to sound, and/or power to the tool 50 to be shut off. Thus, theocclusion detection algorithm prevents the tool 50 from damaging theanatomy when the tracking system 40 is not able to track a relativeposition of the tool 50 and the anatomy. For example, in one embodiment,if the occlusion detection algorithm detects an occluded state, thesurgical system 10 determines whether the tool 50 is touching a hapticboundary of a haptic object. If the tool 50 is not in contact with ahaptic boundary, the occlusion detection algorithm places the hapticdevice 30 in the free mode so that the tool 50 will move with thepatient and, if necessary, can be withdrawn from the patient. When theoccluded state ends (e.g., when an occluded tracker again becomesvisible), the surgical system 10 places the haptic device 30 in theapproach mode so that the user may resume the procedure. In contrast, ifthe surgical system 10 determines that the tool 50 is touching thehaptic boundary during the occluded state, the occlusion detectionalgorithms waits for a predetermined period of time (e.g., 1 second) tosee if the occluded tracker becomes visible. If the haptic devicetracker 45 and the anatomy trackers 43 a and 43 b all become visiblewithin the predetermined period of time, the haptic (or burring) mode isresumed. Otherwise, the haptic device 30 is placed in the free mode sothat the tool 50 will move with the patient and, if necessary, can bewithdrawn from the patient. As before, when the occluded state ends(e.g., when an occluded tracker again becomes visible), the surgicalsystem 10 places the haptic device 30 in the approach mode so that theuser may resume the procedure.

Once the haptic device 30 enters the haptic mode, the user may proceedwith bone sculpting. To sculpt the bone, the user manipulates the hapticdevice 30 by moving a portion of the haptic device 30 (e.g., the tool50) in a region of the anatomy (e.g., the bone). As best seen in FIG.37, as the user removes material from the bone with the tool 50, thesurgical system 10 updates the image of the tibia T on the screen 89 toshow a depth to which bone has been removed. During the bone removalprocess, the haptic device 30 imparts force feedback to the user, forexample, based on a haptic object (e.g., the haptic object 206 in FIG.9) having a shape and volume corresponding to the portion 618 of bone tobe removed. For the medial tibial surface feature, a boundary of thehaptic object may substantially correspond, for example, to the surface74 a (shown in FIG. 10b ) of the tibial component 74 that will mate withthe sculpted surface of the tibia T. The force feedback encourages theuser to keep the tip of the tool 50 within the boundaries of the hapticobject. For example, the force feedback may constrain the tool 50against penetrating at least a portion of the haptic object, such as avirtual boundary. Although the haptic object is virtual and the tool 50moves in physical space, the surgical system 10 associates the anatomy,the haptic object, and the haptic device 30 with the representation ofthe anatomy. Thus, the haptic object and the tool 50 are both inregistration with the physical anatomy of the patient. As a result, thevirtual haptic object is able to bound or constrain movement of thephysical tool 50.

In addition to haptically guiding the user in the bone sculptingprocess, the surgical system 10 may also provide visual feedback to theuser. For example, when the tool 50 reaches a desired cutting depth in aparticular location of the portion 618, the color of the particularlocation may change from green to white to indicate that no more boneshould be removed from that location. Similarly, if the tool 50 cutsbeyond the desired cutting depth, the color of the particular locationmay change from white to red to alert the user that the cut is too deep.To further reduce the possibility of damage to healthy tissue, thesurgical system 10 may also be programmed to disable power to the tool50 should the user cut too deeply. When sculpting of the medial tibialpocket feature is complete, the user may signal (e.g., using a footpedal or other input device 25) that he is ready to proceed to formingthe next feature or that he wishes to withdraw the tool 50. The tool 50may be withdrawn at any time during the sculpting process even if thefeature is not complete. For example, the user may wish to withdraw thetool 50 to replace the tool tip, irrigate the surgical site, perform atrail reduction, revisit implant planning, address a problem that hasarisen, or the like. If the user signals that he wants to withdraw thetool 50, the occlusion detection algorithm is halted and the hapticdevice 30 is placed in the free mode to enable withdrawal of the tool50.

Step S12 is a trial reduction process in which the first implant (i.e.,the tibial component 74) or a trial implant (e.g., a tibial trial) isfitted to the first bone (i.e., the prepared medial tibial pocketfeature on the tibia T). The user assesses the fit of the tibialcomponent or the tibial trial and may make any desired adjustments, suchas, for example, repeating implant planning and/or bone sculpting toachieve an improved fit.

In step S13, the user plans bone preparation for implanting a secondimplant on a second bone after preparing the first bone. In a preferredembodiment, the second bone is the femur F, the second implant is thefemoral component 72, and bone preparation is planned by selecting alocation on a distal end of the femur F where the femoral component 72will be installed. If the femoral component 72 has been previouslyplanned (e.g., in step S10), the prior placement may be revisited andadjusted if desired. As in step S10, the surgical system 10 facilitatesimplant planning by generating a screen 88 a (shown in FIG. 38). Thescreen 88 a is similar to the screen 88 b (shown in FIG. 35) used forplanning of the tibial component 74 except the frames 800, 802, 804,806, and 807 include images, data, and selection buttons relevant toplacement of the femoral component 72, including a representation (orimplant model) 808 b of the second implant (i.e., the femoral component72).

The location of the femoral component 72 may be determined, for example,relative to the position of pre-existing implants and surroundingstructures. These points may be mapped using a tracked tool in the samemanner as the cartilage points in step S10 above. The mapped points mayinclude points on anatomic structures in the joint (e.g., bone, nerves,soft tissue, etc.) and/or points on pre-existing implants in the joint(e.g., edges, corners, surfaces, verification features, divots, grooves,centerline markings, etc.). The pre-existing implants may include, forexample, the first implant (i.e., the tibial component 74), a trialimplant (e.g., the tibial trial), and/or an existing implant from aprior surgery. The points may be selected with the leg L at variousangles from full extension to full flexion. For example, points may bemapped with the leg L in full extension, at 90°, and in full flexion. Inone embodiment, the knee joint is moved to a first position (e.g., oneof flexion and extension), the user identifies a first pointcorresponding to a first location in the joint when the joint is in thefirst position, the knee joint is moved to a second position (e.g., theother of flexion and extension), and the user identifies a second pointcorresponding to a second location in the joint when the joint is in thesecond position. The surgical system 10 displays the first and secondpoints in the frame 800 on the screen 88 a as points 810. The points 810aid the user in visualizing placement of the second implant (i.e., thefemoral component 72). Thus, the user is able to plan bone preparationfor implanting the second implant on the second bone based at least inpart on the first and second points.

In one embodiment, the size and position of the femoral component 72 aredetermined by mapping a first point at a centerline on an anterior edgeof the tibial trial implant with the leg in extension and a second pointat the centerline on the anterior edge of the tibial trial implant withthe leg in flexion. The extension point is used to size the femoralcomponent 72. For example, the size of the femoral component 72 may beselected so that the tibial component 74 will not ride off an anterioredge of the femoral component 72 as the knee moves into extension. Theflexion and extension points together are used to determine theinternal/external rotation of the femoral component 72 to ensure thatthe femoral component 72 properly rides on the tibial component 74(e.g., based on the patient's natural range of motion and jointkinematics). For example, a centerline of a representation of the secondimplant (e.g., a representation of the keel 72 c of the femoralcomponent 72) may be aligned with the flexion and extension points.Optionally, a point on the posterior “cut” edge may be used to determinethe posterior placement of the femoral component 72. In this embodiment,the user selects a location for the femoral component 72 by moving theimplant model 808 a (shown in FIG. 38) to the general implantation area.Using the transverse view in the frame 806, the user adjusts the implantmodel 808 a rotationally so that a centerline of the implant model 808 aaligns with the mapped points 810 representing the centerline of thetibial trial implant in extension and flexion. An internal/externalangle dimension (designated “External”) in the frame 807 displays theresulting internal/external angle. Using the coronal view in the frame804, the user adjusts the varus/valgus angle of the implant model 808 a.A varus/valgus (designated “Valgus”) angle dimension in the frame 807displays the resulting varus/valgus angle. Using the sagittal view inthe frame 802, the user adjusts the posterior rotation of the implantmodel 808 a. A flexion angle dimension (designated “Flexion”) in theframe 807 displays the resulting flexion angle. In one embodiment, theposterior rotation is adjusted so that the stem of the femoral component72 is within a range of approximately 5° to approximately 8° of theanatomical axis of the bone image. The user may adjust a distal depth ofthe implant model 808 a in the femur F by adjusting a depth bar(designated “Depth”) in the frame 807. The user may also change the sizeof the implant model 808 a using a size selection box (designated“Size”) in the frame 807. In this manner, the representation of thesecond implant (the implant model 808 a) is associated with therepresentation of the second bone (i.e., the femur F) based at least inpart on a detected location of the first implant on the first bone(i.e., the tibia T).

In step S14, the second bone is prepared to receive the second implantby manipulating the tool 50 to sculpt the second bone. In oneembodiment, the femur F is prepared by forming the medial femoralsurface, post, and keel features on the distal end of the femur F. Uponinstallation of the femoral component 72, the medial femoral surface,post, and keel features will mate with a surface 72 a, a post 72 b, anda keel 72 c, respectively, of the femoral component 72 (shown in FIG.10A). Preparation of the femoral features is substantially similar tothe preparation of the medial tibial surface feature. As shown in FIG.39, the surgical system 10 displays a screen 91 showing a graphicalrepresentation of the femur F. As with the screen 89 for tibiapreparation, the screen 91 includes the representation 612 of theportion 618 of bone to be removed and a graphical representation of thetool 50 showing the tool tip 616 a and a tool shaft 616 b. The screen 91may optionally display a position of the opposite bone (i.e., the tibiaT) to guide the user in avoiding accidental cutting of a surface of theopposite bone. As before, the portion 618 of bone to be removed ispreferably colored a different color from the surrounding bone. Thehaptic device 30 enters the approach mode in which a haptic object(e.g., the haptic object 300 in FIG. 1, the haptic object 310 in FIG. 9)in the form of an approach path assists the user in guiding the tip ofthe tool 50 through the incision 128 and toward the feature of intereston the patient (i.e., the portion of bone on the patient's anatomycorresponding to the portion 618 graphically represented on the screen91). The surgical system 10 automatically places the haptic device 30 inthe haptic (or burring) mode, for example, when the tip of the tool 50approaches a predefined point related to the feature of interest. Whenthe haptic device 30 is placed in the haptic mode, the surgical system10 also initiates the occlusion detection algorithm.

Once the haptic device 30 enters the haptic mode, the user may proceedwith bone sculpting. As shown in FIG. 39, as the user removes bone withthe tool 50, the surgical system 10 updates the image of the femur F onthe screen 91 to show a depth to which bone has been removed. During thebone removal process, the haptic device 30 imparts force feedback to theuser, for example, based on a haptic object (e.g., a haptic object 208shown in FIG. 9) having a shape and volume corresponding to the portion618 of bone to be removed. For the medial femoral surface feature, aboundary of the haptic object may substantially correspond, for example,to the surface 72 a (shown in FIG. 10A) of the femoral component 72 thatwill mate with the sculpted surface of the femur F. The force feedbackencourages the user to keep the tip of the tool 50 within the boundariesof the haptic object.

During sculpting, the user may desire to change the tool 50. Forexample, in one embodiment, the user uses a 6 mm burr to form most ofthe medial femoral surface feature and a 2 mm to sculpt the “corners”(e.g., regions where a vertical wall of the feature transitions to ahorizontal bottom of the feature). To replace the burr, the user signalsthat he wants to withdraw the tool 50. In response, the occlusiondetection algorithm is halted and the haptic device 30 is placed in thefree mode to enable withdrawal of the tool 50. Once the burr has beenreplaced, the haptic device 30 may be placed in the approach mode toenable the user to direct the tool 50 to the surgical site to finishforming the medial femoral surface feature. In a preferred embodiment,prior to recommencing sculpting, the user touches the tool 50 (or atracked probe) to a mark that was placed on the bone (e.g., the femur For the tibia T) during the initial registration in step S8. The markfunctions as a check point that enables the surgical system 10 to verifyproper system configuration. For example, the check point can be used toverify that the tracking system 40 is properly configured (e.g.,trackers still properly aligned relative to the anatomy, not blocked oroccluded, etc.), that that the tool 50 is correctly installed (e.g.,property seated, shaft not bent, etc.), and/or that any other object isproperly mounted, installed, set up, etc. If the check reveals a problemwith the system configuration (e.g., one of the trackers was bumped bythe user during the tool change and is now misaligned), registration(step S8) must be repeated. This check point verification may beperformed anytime the user desires to validate the system configurationsuch as when the tool 50 is withdrawn from and then reinserted into thepatient. When sculpting of the medial femoral surface feature iscomplete, the user may signal (e.g., using a foot pedal or other inputdevice 25) that he is ready to proceed to forming the medial femoralpost feature. In one embodiment, prior to forming the medial postfeature, the user replaces the 2 mm burr used to form the corners of themedial femoral surface feature with a 4 mm burr.

The process for sculpting the medial femoral post feature issubstantially similar to the process for sculpting the medial femoralsurface feature. As with the femoral surface feature, the surgicalsystem 10 displays the screen 91 (shown in FIG. 39) showing thegraphical representation of the femur F, the representation 612 of theportion 618 of bone to be removed, a representation of the tool 50showing a representation the tool tip 616 a and a representation of thetool shaft 616 b, and optionally a representation of the opposite bone(i.e., the tibia T). As before, the portion 618 of bone to be removed ispreferably colored a different color from the surrounding bone. In oneembodiment, the surgical system 10 displays only the representation ofthe tip 616 a of the tool 50 in the screen 91. However, due to thecriticality of an approach angle of the tool 50 in forming the post andkeel features, the surgical system 10 preferably indicates an allowableangle of inclination of the shaft of the tool 50 when the post and keelfeatures are being sculpted. For example, the representation of theshaft 616 b may be displayed so that the user is able to see how theshaft 616 b is oriented with respect to the anatomy. Thus, the user candetermine whether the shaft is rubbing against a previously sculptedbone wall (or other object) as the user sculpts deeper portions of thefemoral features. A numerical value of a tool angle (e.g., an angle ofinclination) may also be shown the screen 91. The surgical system 10 mayalso include a haptic object shaped so as to constrain an angle of theshaft of the tool 50 to a predetermined value. In one embodiment, thepredetermined value is such that the shaft of the tool 50 remainssubstantially perpendicular to a plane of bone into which the tool 50 iscutting. For example, the predetermined value may be in a range of about80° to about 90° from the plane of bone into which the tool 50 iscutting. The screen 91 may also include a graphical depiction of thehaptic object that constrains the shaft and may change the color of thehaptic object (e.g., to red) if the tool angle exceeds the predeterminedvalue. Additionally or alternatively, the tool 50 may include a sleevedisposed about the shaft and/or the tip of the tool 50 that prevents therotating shaft and/or tip from coming into direct contact with bone.

The haptic device 30 enters the approach mode in which a haptic object(e.g., the haptic object 300 in FIG. 1, the haptic object 310 shown inFIG. 9) in the form of an approach path assists the user in guiding thetip of the tool 50 toward the feature of interest on the patient (i.e.,the portion of bone on the patient's anatomy corresponding to theportion 618 graphically represented on the screen 91). The surgicalsystem 10 automatically places the haptic device 30 in the haptic (orburring) mode, for example, when the tip of the tool 50 approaches apredefined point related to the feature of interest. If the occlusiondetection algorithm was previously halted (e.g., to withdraw the tool 50after formation of the femoral surface feature), the surgical system 10initiates the occlusion detection algorithm when the haptic device 30enters the haptic mode.

Once the haptic device 30 enters the haptic mode, the user may proceedwith bone sculpting. As the user removes bone with the tool 50, thesurgical system 10 updates the image of the femur F on the screen 91 toshow a depth to which bone has been removed. During the bone removalprocess, the haptic device 30 imparts force feedback to the user, forexample, based on a haptic object having a shape and volumecorresponding to the portion 618 of bone to be removed. For the medialfemoral post feature, a boundary of the haptic object may substantiallycorrespond, for example, to a surface of the post 72 b (shown in FIG.10A) of the femoral component 72 that will mate with the sculptedsurface of the femur F. When the medial femoral post feature iscomplete, the user may signal (e.g., using a foot pedal or other inputdevice 25) that he is ready to proceed to forming the medial femoralkeel feature. In one embodiment, prior to forming the keel feature, theuser replaces the 4 mm burr with a straight burr. As discussed above inconnection with the corners of the medial femoral surface feature, toreplace the burr, the user signals that he needs to withdraw the tool50. In response, the occlusion detection algorithm is halted and thehaptic device 30 is placed in the free mode to enable withdrawal of thetool 50. Once the burr has been replaced, the user may proceed withforming the medial femoral keel feature. Preferably, the user performsthe above-described check point verification prior to recommencing bonesculpting.

The process for sculpting the medial femoral keel feature issubstantially similar to the process for sculpting the medial femoralsurface and post features. As with the femoral surface and postfeatures, the surgical system 10 displays the screen 91 (shown in FIG.39) showing the graphical representation of the femur F, therepresentation 612 of the portion 618 of bone to be removed, a graphicalrepresentation of the tool 50 showing the tool tip 616 a and a toolshaft 616 b, and optionally a representation of the opposite bone (i.e.,the tibia T). As before, the portion 618 of bone to be removed ispreferably colored a different color from the surrounding bone.Additionally, as discussed above in connection with the medial femoralpost feature, the screen 91 may include features that enable the user tomonitor tool angle to avoid damaging surrounding bone with the rotatingshaft of the tool 50.

The haptic device 30 enters the approach mode in which a haptic object(e.g., the haptic object 300 in FIG. 1, the haptic object 310 shown inFIG. 9) in the form of an approach path assists the user in guiding thetip of the tool 50 through the incision 128 and toward the feature ofinterest on the patient (i.e., the portion of bone on the patient'sanatomy corresponding to the portion 618 graphically represented on thescreen 91). The surgical system 10 automatically places the hapticdevice 30 in the haptic (or burring) mode, for example, when the tip ofthe tool 50 approaches a predefined point related to the feature ofinterest. When the haptic device 30 enters the haptic mode, the surgicalsystem 10 also initiates the occlusion detection algorithm. Once thehaptic device 30 enters the haptic mode, the user may proceed with bonesculpting. As the user removes bone with the tool 50, the surgicalsystem 10 updates the image of the femur F on the screen 91 to show adepth to which bone has been removed. During the bone removal process,the haptic device 30 imparts force feedback to the user, for example,based on a haptic object having a shape and volume corresponding to theportion 618 of bone to be removed. For the medial femoral keel feature,a boundary of the haptic object may substantially correspond, forexample, to a surface of the keel 72 c (shown in FIG. 10A) of thefemoral component 72 that will mate with the sculpted surface of thefemur F. When the medial femoral keel feature is complete, the user maysignal (e.g., using a foot pedal or other input device 25) that he isready to withdraw the tool 50 from the patient. In response, thesurgical system 10 halts the occlusion detection algorithm and placesthe haptic device 30 in the free mode to enable retraction of the tool50.

Step S15 is a trial reduction process in which the second implant (i.e.,the femoral component 72) or a trial implant (e.g., a femoral trial) isfitted to the prepared medial femoral surface, post, and keel featureson the femur F. The user assesses the fit of the femoral component 72 orthe femoral trial and may make any desired adjustments, such as, forexample, repeating implant planning and/or bone sculpting to achieve animproved fit. In step S15, adjustments may also be made to the tibia T.To facilitate trial reduction, the surgical system 10 may generate ascreen (not shown) that graphically represents the tracked movement ofthe femur F and the tibia T and displays measurements, such as, forexample, flexion, varus/valgus, and internal/external rotation angles.Additionally, the femoral and/or tibial trial implants may includeintrinsic features (e.g., divots, markings, etc.) that can be touchedwith a tracked probe after the trial implant is fitted to the bone toenable the surgical system 10 to verify placement of the trial implant.The intrinsic features may also be used to key a position of one implantto another implant (e.g., in the case of a modular implant). When theuser is satisfied with the fit of the trial implants, the user mayproceed with installation of the femoral component 72 and the tibialcomponent 74 and completion of the surgical procedure.

Thus, embodiments of the present invention provide a haptic guidancesystem and method that may replace direct visualization in minimallyinvasive surgery, spare healthy bone in orthopedic joint replacementapplications, enable intraoperative adaptability and planning, andproduce operative results that are sufficiently predictable, repeatable,and/or accurate regardless of surgical skill level.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only.

What is claimed is:
 1. A method for controlling a surgical tool,comprising: associating a joint of a patient with a representation ofthe joint; collecting data indicating at least one of a position and anorientation of a first bone and a second bone of the joint as the jointis moved through a range of motion; creating a surgical plan based atleast in part on the data collected; establishing a virtual cuttingboundary on the representation of the joint based on the surgical plan;superimposing a representation of the surgical tool on therepresentation of the joint, wherein the surgical tool is to be operatedby a user to execute the surgical plan during a surgical procedure; andcontrolling the surgical tool to prevent the surgical tool from cuttinga portion of the joint outside a boundary that corresponds to thevirtual cutting boundary.
 2. The method of claim 1, wherein creating asurgical plan comprises planning bone preparation for implanting a firstimplant on the first bone of the joint.
 3. The method of claim 2,wherein planning bone preparation for implanting the first implantincludes associating a representation of the first implant with arepresentation of the first bone.
 4. The method of claim 2, furthercomprising preparing the first bone of the joint according to thesurgical plan, wherein preparing the first bone comprises the steps of:superimposing a representation of a portion of material to be removedfrom the first bone on a representation of the first bone; and updatingthe representation of the portion of material to be removed from thefirst bone with a representation of a portion of material actuallyremoved by the surgical tool.
 5. The method of claim 4, wherein theportion of material to be removed corresponds to the virtual cuttingboundary associated with the representation of the joint.
 6. The methodof claim 2, wherein creating a surgical plan further comprises planningbone preparation for implanting a second implant on the second bone ofthe joint.
 7. The method of claim 6, wherein planning bone preparationfor implanting the second implant includes associating a representationof the second implant on a representation of the second bone.
 8. Themethod of claim 6, further comprising preparing the second bone of thejoint according to the surgical plan, wherein preparing the second boneincludes: superimposing a representation of a portion of material to beremoved from the second bone on a representation of the second bone; andupdating the representation of the portion of material to be removedfrom the second bone with a representation of a portion of materialactually removed by the surgical tool.
 9. The method of claim 8, whereinthe portion of material to be removed corresponds to the virtual cuttingboundary associated with the representation of the second bone.
 10. Themethod of claim 1, further comprising monitoring movement of the firstbone, the second bone, and the surgical tool, and updating therepresentation of the joint and the virtual cutting boundary in responseto movement of the first bone and/or the second bone.
 11. The method ofclaim 1, wherein controlling the surgical tool to prevent the surgicaltool from cutting a portion of the joint outside the boundary thatcorresponds to the virtual cutting boundary comprises controlling thesurgical tool so that a tip of the surgical tool is prevented againstpenetrating the boundary while cutting.
 12. A surgical system,comprising: a surgical tool configured to be manipulated by a user toexecute a surgical plan during a surgical procedure; a computer systemconfigured to: associate a joint of a patient with a representation ofthe joint; collect data indicating at least one of a position and anorientation of a first bone and a second bone of the joint as the jointis moved through a range of motion; create a surgical plan based atleast in part on the data collected; establish a virtual cuttingboundary on the representation of the joint based on the surgical plan;superimpose a representation of the surgical tool on the representationof the joint; and control the surgical tool to prevent the surgical toolfrom cutting a portion of the joint outside a boundary that correspondsto the virtual cutting boundary.
 13. The surgical system of claim 12,further comprising a display for displaying at least one of therepresentation of the joint and the virtual cutting boundary.
 14. Thesurgical system of claim 12, further comprising a tracking system formonitoring movement of the first bone, the second bone, and the surgicaltool, and wherein the computer system is further configured to updatethe representation of the joint and the virtual cutting boundary inresponse to movement of the first bone and/or the second bone.
 15. Thesurgical system of claim 12, wherein creating a surgical plan comprisesplanning bone preparation for implanting a first implant on the firstbone of the joint.
 16. The surgical system of claim 15, wherein thecomputer system is further configured to: superimpose a representationof a portion of material to be removed from the first bone on arepresentation of the first bone; and update the representation of theportion of material to be removed from the first bone with arepresentation of a portion of material actually removed by the surgicaltool.
 17. The surgical system of claim 16, wherein the portion ofmaterial to be removed corresponds to the virtual cutting boundaryassociated with the representation of the joint.
 18. The surgical systemof claim 15, wherein creating a surgical plan further comprises planningbone preparation for implanting a second implant on the second bone ofthe joint.
 19. The surgical system of claim 18, wherein the computersystem is further configured to: superimpose a representation of aportion of material to be removed from the second bone on arepresentation of the second bone; and update the representation of theportion of material to be removed from the second bone with arepresentation of a portion of material actually removed by the surgicaltool.
 20. The surgical system of claim 12, wherein controlling thesurgical tool to prevent the surgical tool from cutting a portion of thejoint outside the boundary that corresponds to the virtual cuttingboundary comprises controlling the surgical tool so that a tip of thesurgical tool is prevented against penetrating the boundary whilecutting.